D-dimer IVD, kit, agglutination - UK MHRA Medical Device Registration
D-dimer IVD, kit, agglutination is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 116333. 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.
Device Type
In Vitro Diagnostic Device
Devices
D-dimer IVD, kit, agglutination
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Nov 23, 2024
Address
180 Hartwell Road
Bedford, United States
Created Date
Dec 1, 2021
Name
Werfen LtdRelationship Type
Address
712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester
Manchester, England, United Kingdom
Postcode: WA3 6DE
Clostridium difficile antigen IVD, antibody
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Troponin I IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Troponin T IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Rotavirus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Total triiodothyronine (TT3) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Prolactin IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Blood gas/haemoximetry analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Blood gas/haemoximetry analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered sample diluent IVD, manual
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered sample diluent IVD, manual
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered wash solution IVD, manual
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Coagulation factor VII IVD, kit, clotting
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Activated partial thromboplastin time (APTT) IVD, kit, clotting
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Fibrinogen assay (factor I) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
General laboratory container, single-use
Type: System or Procedure Pack
Manufacturer: Instrumentation Laboratory Co
Laboratory analyser cuvette IVD, single-use
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
Laboratory analyser cuvette IVD, single-use
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
Laboratory waste receptacle IVD
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
Multiple electrolyte IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co
Direct thrombin inhibitor therapeutic drug monitoring IVD, kit, clotting
Type: In Vitro Diagnostic Device
Manufacturer: Instrumentation Laboratory Co

