BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

BK virus (BKV) 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 135830. The device is manufactured by TIB Molbiol Syntheselabor Gmbh from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 135830•Ref: 135830

Device Type

In Vitro Diagnostic Device

Devices

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

TIB Molbiol Syntheselabor Gmbh

Address

Eresburgstraße 22–23

Berlin, Germany

Created Date

Feb 9, 2022

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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BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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