Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration
Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 137294. The device is manufactured by NeoMedica doo from Serbia, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang 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.
Device Type
In Vitro Diagnostic Device
Devices
Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type
IVD General
Date Registered
Apr 11, 2024
Last Updated
Oct 17, 2023
Name
Wellkang LtdRelationship Type
Address
Enterprise Hub, NW Business Complex 1 Beraghmore Road
Derry, Northern Ireland, Northern Ireland, United Kingdom
Postcode: BT48 8SE
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Aldosterone IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Aldosterone IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Aldosterone IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Alpha-fetoprotein (AFP) IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Anti-Mullerian hormone (AMH) IVD, control
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Borrelia afzelii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 11, 2024
Arterial tourniquet, manual, single-use
Type: General Medical Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
Assay container IVD, single-use
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
Assay container IVD, single-use
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
Blood smearing manual instrument IVD
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
Centrifuge tube IVD
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
Faecal specimen container IVD, transport buffer/medium
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
General laboratory container, reusable
Type: General Medical Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
General specimen container IVD, no additive/medium
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
General specimen microscopy slide IVD, single-use
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.
Amies transport medium IVD
Type: In Vitro Diagnostic Device
Manufacturer: Citotest Labware Manufacturing Co., Ltd.

