United Kingdom MHRA device registration 156142

Treponema pallidum reagin antibody IVD, kit, agglutination

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Gold Standard Diagnostics·Registered Nov 26, 2024
Registration details
Device ID
156142
MHRA Reference Number
156142
Date Registered
Nov 26, 2024
Last Updated
Apr 5, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Treponema pallidum reagin antibody IVD, kit, agglutination
Type
IVD General
Manufacturer
Address
2795 2nd Street Suite 300
Davis, CA, United States
Created Date
Sep 14, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
Unit 20 Ash Way Thorp Arch Estate
Wetherby, England, United Kingdom
Postcode: LS23 7FA
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About this record

Treponema pallidum reagin antibody IVD, kit, agglutination is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 156142. The device is manufactured by Gold Standard Diagnostics from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

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.

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