Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125585. The device is manufactured by INOVA Diagnostics from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen Ltd.

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Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay

MHRA Device ID: 125585•Ref: 125585

Device Type

In Vitro Diagnostic Device

Devices

Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 22, 2024

Manufacturer Information

Name

INOVA Diagnostics

Address

9900 Old Grove Road

San Diego, United States

Created Date

Dec 21, 2021

Authorized Representative

Name

Werfen Ltd

Relationship Type

UK Responsible Person

Address

712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester

Manchester, England, United Kingdom

Postcode: WA3 6DE

DJ Fang

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Multiple antinuclear antibody (ANA) screening IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

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