Instrument/analyser specimen/reagent container carrier IVD - UK MHRA Medical Device Registration
Instrument/analyser specimen/reagent container carrier IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 126249. The device is manufactured by BIOKIT S.A. from Spain, 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
Instrument/analyser specimen/reagent container carrier IVD
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Aug 21, 2024
Name
BIOKIT S.A.Address
Av. Can Montcau, 7 08186 Lliรงร d'Amunt
Barcelona, Spain
Created Date
Aug 20, 2021
Name
Werfen LtdRelationship Type
Address
712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester
Manchester, England, United Kingdom
Postcode: WA3 6DE
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Laboratory instrument/analyser rinse fluid tank IVD
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
D-dimer IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered wash solution IVD, manual
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Chemiluminescent immunoassay analyser IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Chemiluminescent immunoassay analyser IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered sample diluent IVD, manual
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
D-dimer IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Digitoxin therapeutic drug monitoring IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Beta-2-microglobulin IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
Buffered sample diluent IVD
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
Buffered sample diluent IVD, automated/semi-automated system
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
Culture tube
Type: General Medical Device
Manufacturer: BIOKIT S.A.
D-dimer IVD, calibrator
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
Ferritin IVD, calibrator
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.
Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
Type: In Vitro Diagnostic Device
Manufacturer: BIOKIT S.A.

