BK virus (BKV) nucleic acid IVD, calibrator - UK MHRA Medical Device Registration

BK virus (BKV) nucleic acid IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 180900. The device is manufactured by Abbott Molecular Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Abbott Laboratories 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

🇬🇧

BK virus (BKV) nucleic acid IVD, calibrator

MHRA Device ID: 180900•Ref: 180900

Device Type

In Vitro Diagnostic Device

Devices

BK virus (BKV) nucleic acid IVD, calibrator

Type

Class C

Date Registered

Nov 26, 2024

Last Updated

Apr 25, 2024

Manufacturer Information

Name

Abbott Molecular Inc.

Address

1350 E. Touhy Ave

Des Plaines, IL, Illinois, United States

Created Date

Mar 29, 2021

Authorized Representative

Name

Abbott Laboratories Limited

Relationship Type

UK Responsible Person

Address

Abbott House, Vanwall Business Park, Vanwall Road

Maidenhead, Berkshire, England, United Kingdom

Postcode: SL64XE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Abbott Molecular Inc. (10)

Other Products from Same Authorized Representative (10)

BK virus (BKV) nucleic acid IVD, calibrator - 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

B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, probe

B-cell malignancy IVD, kit, nucleic acid technique (NAT)

B-cell malignancy IVD, reagent

Cancer/tumour-associated aneuploidy IVD, probe

Cytology specimen container IVD, transport buffer

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

Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)

Hepatitis C virus nucleic acid IVD, control

Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Buffered wash solution IVD, automated/semi-automated system

Chemiluminescent immunoassay oxidizing reagent IVD

Beta-haemolytic Group A Streptococcus hyaluronidase antibody IVD, kit, enzyme immunoassay (EIA)

Buffered sample diluent IVD, manual

Cancer antigen 72-4 (CA 72-4) IVD, kit, chemiluminescent immunoassay

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

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

Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent

Buffered sample diluent IVD

Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator