United Kingdom MHRA device registration 92330

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Immucor GTI Diagnostics, Inc.·Registered Nov 26, 2024
Registration details
Device ID
92330
MHRA Reference Number
92330
Date Registered
Nov 26, 2024
Last Updated
Jun 7, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)
Type
IVD General
Manufacturer
Address
20925 Crossroad Circle
Waukesha, Wisconsin, United States
Created Date
Aug 4, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP
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About this record

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 92330. The device is manufactured by Immucor GTI Diagnostics, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting Ltd.

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