United Kingdom MHRA device registration 153744

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

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·JINAN BABIO BIOTECHNOLOGY CO., LTD.·Registered Nov 26, 2024
Registration details
Device ID
153744
MHRA Reference Number
153744
Date Registered
Nov 26, 2024
Last Updated
Mar 13, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type
IVD General
Manufacturer
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
Relationship Type
UK Responsible Person
Address
59 St. Martin's Lane
London, Middlesex, England, United Kingdom
Postcode: WC2N 4JS
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About this record

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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