Prothrombin time (PT) IVD, calibrator - UK MHRA Medical Device Registration

Prothrombin time (PT) IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 116342. The device is manufactured by Instrumentation Laboratory Co from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen Ltd.

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

🇬🇧

Prothrombin time (PT) IVD, calibrator

MHRA Device ID: 116342•Ref: 116342

Device Type

In Vitro Diagnostic Device

Devices

Prothrombin time (PT) IVD, calibrator

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 23, 2024

Manufacturer Information

Name

Instrumentation Laboratory Co

Address

180 Hartwell Road

Bedford, United States

Created Date

Dec 1, 2021

Authorized Representative

Name

Werfen Ltd

Relationship Type

UK Responsible Person

Address

712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester

Manchester, England, United Kingdom

Postcode: WA3 6DE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Instrumentation Laboratory Co (10)

Other Products from Same Authorized Representative (10)

Prothrombin time (PT) 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

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Multiple respiratory virus antigen IVD, kit, rapid ICT, clinical

Myoglobin IVD, kit, fluorescent immunoassay

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

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)

Blood gas/haemoximetry analyser IVD, laboratory

Blood gas/haemoximetry analyser IVD, laboratory

Buffered sample diluent IVD, manual

Buffered sample diluent IVD, manual

Buffered wash solution IVD, manual

Coagulation factor VII IVD, kit, clotting

Activated partial thromboplastin time (APTT) IVD, kit, clotting

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent

Buffered sample diluent IVD

Buffered sample diluent IVD, automated/semi-automated system

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Culture tube

D-dimer IVD, calibrator

Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination

Ferritin IVD, calibrator

Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry