Oral/upper respiratory tract specimen collection kit - UK MHRA Medical Device Registration

Oral/upper respiratory tract specimen collection kit is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125001. The device is manufactured by OraSure Technologies, Inc. from United States, classified as General Medical 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

MHRA Registered

General Medical Device

🇬🇧

Oral/upper respiratory tract specimen collection kit

MHRA Device ID: 125001•Ref: 125001

Device Type

General Medical Device

Devices

Oral/upper respiratory tract specimen collection kit

Type

Class I

Date Registered

Nov 26, 2024

Last Updated

Oct 22, 2024

Manufacturer Information

Name

OraSure Technologies, Inc.

Address

220 E. 1st Street

Bethlehem, United States

Created Date

Dec 21, 2021

Authorized Representative

Name

Qarad UK Ltd.

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from OraSure Technologies, Inc. (6)

Other Products from Same Authorized Representative (10)

Oral/upper respiratory tract specimen collection kit - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Custom-made talus prosthesis

External orthopaedic fixation system, reusable

Bone nail guidewire, reusable

General-body orifice lubricant, non-sterile

External orthopaedic fixation frame calculation software

External orthopaedic fixation system, reusable

Bone nail driver

Bone nail end-cap

Absorbent underpad, non-antimicrobial, single-use

External orthopaedic fixation system, single-use

HIV1/HIV2 antibody IVD, control

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

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Oral/upper respiratory tract specimen collection kit IVD, clinical

Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical

Hepatitis C virus antibody/antigen IVD, control

Anti-Mullerian hormone (AMH) IVD, kit, rapid ICT, clinical

Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA)

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

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

Dental cavity varnish

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Temporary dental crown/bridge

Coagulation analyser IVD, laboratory

Activated partial thromboplastin time (APTT) IVD, reagent

Carcinoembryonic antigen (CEA) IVD, control