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

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 112018. The device is manufactured by ORGENTEC Diagnostika GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK Ltd..

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Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 112018•Ref: 112018

Device Type

In Vitro Diagnostic Device

Devices

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jun 15, 2024

Manufacturer Information

Name

ORGENTEC Diagnostika GmbH

Address

Carl-Zeiss-Str. 49-51

Mainz, Rheinhessen-Pfalz, Germany

Created Date

Aug 10, 2021

Authorized Representative

Name

Qarad UK Ltd.

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

DJ Fang

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

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