SARS-CoV-2 nucleic acid IVD, control - UK MHRA Medical Device Registration

SARS-CoV-2 nucleic acid IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 144694. The device is manufactured by Exact Diagnostics LLC from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is BIO-RAD LABORATORIES 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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In Vitro Diagnostic Device

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SARS-CoV-2 nucleic acid IVD, control

MHRA Device ID: 144694•Ref: 144694

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 nucleic acid IVD, control

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Apr 16, 2024

Manufacturer Information

Name

Exact Diagnostics LLC

Address

Exact Diagnostics LLC 100 South Jones Street Suite 100

Fort Worth, Texas, United States

Created Date

Apr 14, 2022

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

DJ Fang

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Other Products from Exact Diagnostics LLC (2)

Multiple respiratory virus nucleic acid IVD, control

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Varicella-zoster virus (VZV) nucleic acid IVD, control

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Other Products from Same Authorized Representative (10)

SARS-CoV-2 nucleic acid IVD, control - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

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D-dimer IVD, kit, fluorescent immunoassay

Multiple respiratory virus nucleic acid IVD, control

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Anti-M red blood cell grouping IVD, antibody

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Assay container IVD, single-use