Immunoglobulin-sensitized reagent red blood cell IVD, control - UK MHRA Medical Device Registration
Immunoglobulin-sensitized reagent red blood cell IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 199147. The device is manufactured by Diapro Tıbbi Ürünler Sanayi ve Ticaret A.Ş. from Turkey, 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
Immunoglobulin-sensitized reagent red blood cell IVD, control
Type
IVD Annex II List B
Date Registered
Nov 26, 2024
Last Updated
Aug 21, 2024
Address
İnönü Mah, Gebze Plastikçiler OSB Atatürk Blv. No:25/1 Gebze
Kocaeli, Turkey
Created Date
May 10, 2024
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.
CD38 cell marker IVD, antibody
Type: In Vitro Diagnostic Device
Registered: Mar 27, 2025
ABO/Rh(D)/IgG multiple blood grouping IVD, kit, agglutination
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Aerobic laboratory incubator
Type: System or Procedure Pack
Registered: Nov 26, 2024
Immunohaematology/blood bank analyser IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Mechanical micropipette IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Anti-K (KEL001) red blood cell grouping IVD, antibody
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Progenie Molecular SLU
Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Progenie Molecular SLU
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Progenie Molecular SLU
Tropheryma whipplei nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Progenie Molecular SLU
Multiple bloodstream bacteria nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: T2 Biosystems Inc
Multiple Candida species nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: T2 Biosystems Inc
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: T2 Biosystems Inc
Activated clotting time (ACT) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Accriva Diagnostics
Co-oximetry analyser IVD, point-of-care
Type: In Vitro Diagnostic Device
Manufacturer: Accriva Diagnostics
Aspergillus fumigatus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Progenie Molecular SLU

