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DiaSorin Italia S.p.A. UK Branch

Authorized Representative in the United Kingdom

Central Road

Dartford, England, United Kingdom

Postcode: DA1 5LR

Relationship Type: UK Responsible Person
412 Products Represented
6 Manufacturers
Total Products
412
Manufacturers
6
Device Types
1
Generic Names
331
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (412)
Complete portfolio registered with MHRA

Vitamin B12 IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay oxidizing reagent IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, reagent

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis D virus total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intact fibroblast growth factor 23 (iFGF23) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, reagent

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid marker IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, reagent

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100-beta (S100-B) protein IVD, calibrator

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100-beta (S100-B) protein IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

S100-beta (S100-B) protein IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue polypeptide antigen IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Viral inactivation buffer IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Campylobacter species antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pancreatic elastase (PE) IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thymidine kinase IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thymidine kinase IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coxiella burnetii immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus NS1 antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hantavirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Rickettsia species (spotted fever group) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Rickettsia species (typhus group) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-blood cell primer/calibrator/control material IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, single-use

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rickettsia conorii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin M (IgM total) IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

1,25-Dihydroxy vitamin D3 IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androstenedione IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Androstenedione IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container liner IVD

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone alkaline phosphatase (BALP) IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol (oestradiol) (E2) IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, no additive

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate (vitamin B9) IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis D virus total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser control unit IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, single-use

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, single-use

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, reagent

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin neutralizing antibody IVD, reagent

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue polypeptide antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Molecular Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container liner IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay oxidizing reagent IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double?stranded?DNA?antibody (anti-dsDNA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplasma phagocytophilum immunoglobulin M (IgM) antibody IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bartonella bacilliformis immunoglobulin M (IgM) antibody IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coxiella burnetii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hantavirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rickettsia conorii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin/gamma globulin IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

West Nile virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

1,25-Dihydroxy vitamin D3 IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

1,25-Dihydroxy vitamin D3 IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aldosterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aldosterone IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone alkaline phosphatase (BALP) IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol?(oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate?(vitamin B9) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Midregional pro-adrenomedullin (MR-proADM) IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Midregional pro-adrenomedullin (MR-proADM) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Campylobacter species antigen IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osteocalcin IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osteocalcin IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sex hormone binding globulin (SHBG) IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thymidine kinase IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B12 IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcitonin IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osteocalcin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystic fibrosis IVD, kit, multiplex

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiplex analyser IVD, laboratory

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD, semi-automated

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin?IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis D virus total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis D virus total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human growth hormone (HGH) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor I (IGF1) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Legionella species antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tissue-associated protein/tumour marker IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neonatal thyroid stimulating hormone (neonatal TSH) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neuron-specific enolase (NSE) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Renin IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Renin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella?virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi total antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystic fibrosis IVD, kit, multiplex

Manufacturer:

Luminex Molecular Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

Manufacturer:

Luminex Molecular Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Molecular Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aldosterone IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay adhesive sealing/fixation film IVD

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bartonella bacilliformis immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Chlamydia species immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, control

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rickettsia conorii immunoglobulin G (IgG) antibody IVD, reagent

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcitonin IVD, control

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcitonin IVD, kit, chemiluminescent immunoassay

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus e-antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Acute promyelocytic leukaemia (APL) genetic mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Aldosterone IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Calcitonin IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Clostridium difficile antigen IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Osteocalcin IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Parathyroid hormone (PTH) IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis B virus core total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis B virus e-antigen total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

1,25-Dihydroxy vitamin D3 IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Dengue virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

DiaSorin Molecular LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Bone alkaline phosphatase (BALP) IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Calprotectin IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Thymidine kinase IVD, reagent

Manufacturer:

DiaSorin Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis A virus total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Hepatitis B virus surface total antibody IVD, reagent

Manufacturer:

DiaSorin Italia S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 1, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 1, 2024

Multiplex analyser IVD, laboratory

Manufacturer:

Luminex Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 23, 2021

Data sourced from the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

Last updated: December 2025