Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 191087. The device is manufactured by TestLine Clinical Diagnostics s.r.o from Czechia, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Oxford Biosystems 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

🇬🇧

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 191087•Ref: 191087

Device Type

In Vitro Diagnostic Device

Devices

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 12, 2024

Manufacturer Information

Name

TestLine Clinical Diagnostics s.r.o

Address

Křižíkova 188/68

Brno, Czechia

Created Date

Nov 24, 2022

Authorized Representative

Name

Oxford Biosystems Ltd

Relationship Type

UK Responsible Person

Address

184B Park Drive Milton Park Abingdon

Abingdon, Oxfordshire, United Kingdom

Postcode: OX14 4SE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from TestLine Clinical Diagnostics s.r.o (10)

Other Products from Same Authorized Representative (10)

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

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

D-dimer IVD, kit, fluorescent immunoassay

Borrelia afzelii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Borrelia burgdorferi total antibody IVD, kit, immunoblot

Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

Multiple Bordetella species antibody IVD, reagent

Borrelia burgdorferi total antibody IVD, kit, immunoblot