Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Beta-haemolytic Group A Streptococcus 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 135727. The device is manufactured by Roche Molecular Systems Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 135727•Ref: 135727

Device Type

In Vitro Diagnostic Device

Devices

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

Class B

Date Registered

Nov 26, 2024

Last Updated

Nov 12, 2024

Manufacturer Information

Name

Roche Molecular Systems Inc.

Address

Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg, United States

Created Date

Apr 22, 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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Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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