Oral/upper respiratory tract specimen collection kit IVD, clinical - UK MHRA Medical Device Registration
Oral/upper respiratory tract specimen collection kit IVD, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125002. 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.
Device Type
In Vitro Diagnostic Device
Devices
Oral/upper respiratory tract specimen collection kit IVD, clinical
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Oct 22, 2024
Address
220 E. 1st Street
Bethlehem, United States
Created Date
Dec 21, 2021
Name
Qarad UK Ltd.Relationship Type
Address
8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY
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.
HIV1/HIV2 antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Oral/upper respiratory tract specimen collection kit
Type: General Medical Device
Registered: Nov 26, 2024
Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Hepatitis C virus antibody/antigen IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Citrate IVD, kit, spectrophotometry
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Ethyl glucuronide (EtG) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Ethyl glucuronide (EtG) IVD, kit, mass spectrometry
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Free cortisol/cortisone IVD, calibrator
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Free cortisol/cortisone IVD, kit, liquid chromatography/mass spectrometry (LC/MS)
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
HVA/VMA/5HIAA IVD, calibrator
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Levetiracetam therapeutic drug monitoring IVD, kit, liquid chromatography
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Multiple biogenic amine neurotransmitter IVD, calibrator
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Multiple form 25-hydroxy Vitamin D IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION
Multiple immunosuppressant therapeutic drug monitoring IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: EUREKA S.R.L. LAB DIVISION

