United Kingdom MHRA device registration 152829

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Bioantibody Biotechnology Co., Ltd.·Registered Nov 26, 2024
Registration details
Device ID
152829
MHRA Reference Number
152829
Date Registered
Nov 26, 2024
Last Updated
Oct 8, 2023
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Type
IVD General
Manufacturer
Address
Room 903/905, Building C6, 9 Weidi Road, Nanjing
Jiangsu Province, China
Created Date
Jul 21, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR
Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176179
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176185
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175386
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176184
C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176164
Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176139
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175389
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175394
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175395
D-dimer IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176162
Other products from Bioantibody Biotechnology Co., Ltd.

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by SUNGO Certification Company Limited in the UK

Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Lifereal Biotechnology Co., Ltd.
Device ID: 90732
Nucleic acid sample preparation instrument IVD, semi-automatedNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 132968
General specimen container IVD, additive/mediumNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Device ID: 138875
Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Device ID: 138876
General specimen container IVD, additive/mediumNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 132970
Nucleic acid extraction/isolation kit IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 112099
Isothermal nucleic acid amplification analyser IVD, laboratory, automatedNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Guangzhou Pluslife Biotech Co., Ltd.
Device ID: 153636
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Guangzhou Pluslife Biotech Co., Ltd.
Device ID: 155900
Nucleic acid extraction/isolation kit IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Device ID: 138874
Thermal cycler nucleic acid amplification analyser IVD, laboratoryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Device ID: 132969
About this record

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 152829. 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.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device