Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Multiple congenital aneuploidy screening 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 95027. The device is manufactured by Roche Sequencing Solutions, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 95027•Ref: 95027

Device Type

In Vitro Diagnostic Device

Devices

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

Type

IVD Annex II List B

Date Registered

Sep 1, 2024

Last Updated

Jul 10, 2024

Manufacturer Information

Name

Roche Sequencing Solutions, Inc.

Address

4300 Hacienda Dr.

Pleasanton, United States

Created Date

Aug 16, 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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Other Products from Roche Sequencing Solutions, Inc. (2)

Human genomic analysis interpretive software

Type: In Vitro Diagnostic Device

Registered: Sep 1, 2024

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

Type: In Vitro Diagnostic Device

Registered: Aug 28, 2024

Other Products from Same Authorized Representative (10)

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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