MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 164719. 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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MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 164719•Ref: 164719

Device Type

In Vitro Diagnostic Device

Devices

MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

Class C

Date Registered

Nov 26, 2024

Last Updated

Oct 10, 2024

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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MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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