Inherited thrombophilia IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 191747. The device is manufactured by TIB Molbiol Syntheselabor Gmbh from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 191747•Ref: 191747

Device Type

In Vitro Diagnostic Device

Devices

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

TIB Molbiol Syntheselabor Gmbh

Address

Eresburgstraße 22–23

Berlin, Germany

Created Date

Feb 9, 2022

Authorized Representative

Name

Roche Diagnostics Limited

Relationship Type

UK Responsible Person

Address

Roche Diagnostics Limited Charles Avenue

Burgess Hill, West Sussex, United Kingdom

Postcode: RH15 9RY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from TIB Molbiol Syntheselabor Gmbh (10)

Other Products from Same Authorized Representative (10)

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

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

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Multiple human parainfluenza virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Multiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT)

Human bocavirus (HBoV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Angiotensin converting enzyme (ACE) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Fructose/lactose intolerance IVD, kit, nucleic acid technique (NAT)

Human metapneumovirus (hMPV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)

Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT)

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

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

Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Self-care monitoring/reporting software

Complement components C3/C3c IVD, kit, nephelometry/turbidimetry

Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Ambulatory insulin infusion pump software, patient-dosing

Self-care monitoring/reporting software

Collagen type I cross-linked C-telopeptide IVD, calibrator

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry