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

Monkeypox virus 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 152407. The device is manufactured by Bioantibody Biotechnology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 152407•Ref: 152407

Device Type

In Vitro Diagnostic Device

Devices

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 8, 2023

Manufacturer Information

Name

Bioantibody Biotechnology Co., Ltd.

Address

Room 903/905, Building C6, 9 Weidi Road, Nanjing

Jiangsu Province, China

Created Date

Jul 21, 2022

Authorized Representative

Name

SUNGO Certification Company Limited

Relationship Type

UK Responsible Person

Address

3rd Floor, 70 Gracechurch Street

London, England, United Kingdom

Postcode: EC3V 0HR

DJ Fang

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

Device Type

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Address

DJ Fang

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Monkeypox virus antigen IVD, kit, rapid ICT, clinical