Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 88979. The device is manufactured by Abbott Diagnostics Scarborough, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

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Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical

MHRA Device ID: 88979•Ref: 88979

Device Type

In Vitro Diagnostic Device

Devices

Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

Abbott Diagnostics Scarborough, Inc.

Address

10 Southgate Rd

Scarborough, Maine, United States

Created Date

Jul 2, 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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Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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