Optical laboratory instrument performance standard calibrator/control IVD, reusable - UK MHRA Medical Device Registration

Optical laboratory instrument performance standard calibrator/control IVD, reusable is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 146975. The device is manufactured by Abbott Rapid Diagnostics Jena GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

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In Vitro Diagnostic Device

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Optical laboratory instrument performance standard calibrator/control IVD, reusable

MHRA Device ID: 146975•Ref: 146975

Device Type

In Vitro Diagnostic Device

Devices

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

Abbott Rapid Diagnostics Jena GmbH

Address

Orlaweg 1

Jena, Thuringia, Germany

Created Date

Mar 15, 2021

Authorized Representative

Name

Unipath Limited (trading as Alere International)

Relationship Type

UK Responsible Person

Address

Abbott House Vanwall Road Vanwall Business Park

Maidenhead, Windsor And Maidenhead, England, United Kingdom

Postcode: SL6 4XE

DJ Fang

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Optical laboratory instrument performance standard calibrator/control IVD, reusable - UK MHRA Medical Device Registration

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