United Kingdom MHRA device registration 125002

Oral/upper respiratory tract specimen collection kit IVD, clinical

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·OraSure Technologies, Inc.·Registered Nov 26, 2024
Registration details
Device ID
125002
MHRA Reference Number
125002
Date Registered
Nov 26, 2024
Last Updated
Oct 22, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Oral/upper respiratory tract specimen collection kit IVD, clinical
Type
IVD General
Manufacturer
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
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About this record

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..

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