United Kingdom MHRA device registration 129350

Multiple antinuclear antibody (ANA) screening IVD, calibrator

United Kingdom·In Vitro Diagnostic Device·Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)·Registered Nov 26, 2024

Registration details

Device ID: 129350
MHRA Reference Number: 129350
Date Registered: Nov 26, 2024
Last Updated: Apr 16, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple antinuclear antibody (ANA) screening IVD, calibrator
Type: IVD General

Manufacturer

Name: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Address: 5500 East 2nd St.
Benicia, California, United States
Created Date: Dec 29, 2021

Authorized Representative

Name: BIO-RAD LABORATORIES LIMITED
Relationship Type: UK Responsible Person
Address: The Junction 3rd And 4th Floor, Station Road, Watford, United Kingdom, WD17 1ET
WATFORD, Hertfordshire, England, United Kingdom
Postcode: wd17 1et

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About this record

Multiple antinuclear antibody (ANA) screening IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 129350. The device is manufactured by Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID) from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is BIO-RAD LABORATORIES LIMITED.

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