United Kingdom MHRA device registration 189495

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Gold Standard Diagnostics Frankfurt GmbH·Registered Nov 26, 2024

Registration details

Device ID: 189495
MHRA Reference Number: 189495
Date Registered: Nov 26, 2024
Last Updated: Aug 21, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Gold Standard Diagnostics Frankfurt GmbH
Address: Waldstrasse 23 A6
Dietzenbach, Germany
Created Date: Dec 30, 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

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from Gold Standard Diagnostics Frankfurt GmbH

Additional devices registered by the same manufacturer

Yersinia enterocolitica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Feb 5, 2025

Type: In Vitro Diagnostic Device

Device ID: 210139

Yersinia enterocolitica immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)Feb 5, 2025

Type: In Vitro Diagnostic Device

Device ID: 210138

Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA)Feb 5, 2025

Type: In Vitro Diagnostic Device

Device ID: 210137

Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Feb 5, 2025

Type: In Vitro Diagnostic Device

Device ID: 210135

Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Feb 5, 2025

Type: In Vitro Diagnostic Device

Device ID: 210136

Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 189490

Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 138614

Adenovirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 189456

Clostridium tetani immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 138611

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 189459

Other products from same authorized representative

Additional devices represented by Werfen Ltd in the UK

Alpha-2-antiplasmin IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116368

Anticardiolipin antibody IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116330

Anticardiolipin-B2-glycoprotein I complex antibody IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116331

Barcode readerNov 26, 2024

Type: System or Procedure Pack

Manufacturer: Instrumentation Laboratory Co

Device ID: 148711

Coagulation analyser IVD, laboratoryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116318

Coagulation factor II (prothrombin) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116347

Coagulation factor V IVD, kit, clottingNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116348

Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116352

Coagulation factor Xa inhibitor IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116369

ADAMTS13 activity IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Instrumentation Laboratory Co

Device ID: 116379

About this record

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 189495. The device is manufactured by Gold Standard Diagnostics Frankfurt GmbH from Germany, 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device