Pure Global

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125000. The device is manufactured by OraSure Technologies, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK 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
Powered by Pure Global AI
MHRA Registered
In Vitro Diagnostic Device
๐Ÿ‡ฌ๐Ÿ‡ง
HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
MHRA Device ID: 125000โ€ขRef: 125000

Device Type

In Vitro Diagnostic Device

Devices

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

Type

IVD Annex II List A

Date Registered

Nov 26, 2024

Last Updated

Oct 22, 2024

Manufacturer Information

Address

220 E. 1st Street

Bethlehem, United States

Created Date

Dec 21, 2021

Authorized Representative

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from Same Authorized Representative (10)

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.

Cancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.

Dengue virus antigen IVD, kit, chemiluminescent immunoassay

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.

Dengue virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.

Lipoprotein-associated phospholipase A2 (Lp-PLA2) IVD, kit, chemiluminescent immunoassay

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.

Interferon gamma release IVD, kit, enzyme immunoassay (EIA)

Type: In Vitro Diagnostic Device

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Type: In Vitro Diagnostic Device

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Type: In Vitro Diagnostic Device

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

Type: In Vitro Diagnostic Device

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.