Antimicrobial susceptibility analyser IVD - UK MHRA Medical Device Registration

Antimicrobial susceptibility analyser IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 169647. The device is manufactured by Specific Diagnostics LLC from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is bioMérieux UK Ltd.

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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Antimicrobial susceptibility analyser IVD

MHRA Device ID: 169647•Ref: 169647

Device Type

In Vitro Diagnostic Device

Devices

Antimicrobial susceptibility analyser IVD

Type

Class A

Date Registered

Nov 26, 2024

Last Updated

Mar 27, 2024

Manufacturer Information

Name

Specific Diagnostics LLC

Address

130 Baytech Drive San Jose CA 95134

San Jose, California, United States

Created Date

Mar 29, 2023

Authorized Representative

Name

bioMérieux UK Ltd

Relationship Type

UK Responsible Person

Address

Chineham Gate Crockford Lane

Basingstoke, Hampshire, England, United Kingdom

Postcode: RG24 8NA

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Specific Diagnostics LLC (2)

Antibacterial susceptibility testing disc IVD

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

General-microorganism antimicrobial susceptibility culture medium IVD

Type: In Vitro Diagnostic Device

Registered: Nov 26, 2024

Other Products from Same Authorized Representative (10)

Antimicrobial susceptibility analyser IVD - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Multiple respiratory virus antigen IVD, kit, rapid ICT, clinical

Myoglobin IVD, kit, fluorescent immunoassay

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Antibacterial susceptibility testing disc IVD

General-microorganism antimicrobial susceptibility culture medium IVD

Antibacterial minimum inhibitory concentration (MIC) IVD

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Buffered sample diluent IVD, automated/semi-automated system

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

Clostridium difficile antigen IVD, antibody

Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

D-dimer IVD, kit, enzyme immunoassay (EIA)

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)