Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 73968. The device is manufactured by Roche Diagnostics GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

MHRA Device ID: 73968•Ref: 73968

Device Type

In Vitro Diagnostic Device

Devices

Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Type

IVD Annex II List A

Date Registered

Apr 19, 2021

Last Updated

Dec 22, 2022

Manufacturer Information

Name

Roche Diagnostics GmbH

Address

Sandhofer Strasse 116

Mannheim, Germany

Created Date

Apr 19, 2021

Authorized Representative

Name

Roche Diagnostics Limited

Relationship Type

UK Responsible Person

Address

Roche Diagnostics Limited Charles Avenue

Burgess Hill, West Sussex, United Kingdom

Postcode: RH15 9RY

DJ Fang

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Other Products from Roche Diagnostics GmbH (10)

Other Products from Same Authorized Representative (10)

Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

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Last Updated

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Created Date

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Address

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