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 153744. The device is manufactured by JINAN BABIO BIOTECHNOLOGY CO., LTD. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is PureUKCA Ltd.

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

MHRA Device ID: 153744•Ref: 153744

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

Mar 13, 2024

Manufacturer Information

Name

JINAN BABIO BIOTECHNOLOGY CO., LTD.

Address

303, Building 5 of SME Industrialization Base of Biomedical Park, 1777 Dazheng Road, High-tech Zone, Jinan City, 250101, Shandong Province, China

Jinan, Shandong, China

Created Date

Jun 1, 2021

Authorized Representative

Name

PureUKCA Ltd

Relationship Type

UK Responsible Person

Address

59 St. Martin's Lane

London, Middlesex, England, United Kingdom

Postcode: WC2N 4JS

DJ Fang

MedTech Regulatory Expert

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Type: In Vitro Diagnostic Device

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Registered: Nov 26, 2024

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

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