Faecal specimen collection kit IVD, home-use - UK MHRA Medical Device Registration
Faecal specimen collection kit IVD, home-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 159069. The device is manufactured by Alpha-Tec Systems, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MDSS-UK RP 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.
Device Type
In Vitro Diagnostic Device
Devices
Faecal specimen collection kit IVD, home-use
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Oct 10, 2023
Address
1311 SE Cardinal Court, Suite 170
Vancouver, WA, United States
Created Date
Mar 8, 2022
Relationship Type
Address
6 Wilmslow Road, Rusholme
Manchester, England, United Kingdom
Postcode: M14 5TP
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.
Biological stain control IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Faecal parasite specimen concentration kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Faecal specimen container IVD, fixative
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Faecal specimen container IVD, no additive
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Faecal specimen container IVD, transport buffer/medium
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Formalin substitute solution IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
General specimen microscopy slide IVD, single-use
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Neutral buffered formalin IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Sputum specimen liquefaction/decontamination kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Sputum liquefaction/decontamination reagent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple cardiac marker IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Quidel Cardiovascular Inc.
Multiple Borrelia species total antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Quidel Corporation
Full blood count IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Quantimetrix Corporation
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Quidel Cardiovascular Inc.
X-ray tube housing assembly, diagnostic
Type: General Medical Device
Manufacturer: Chronos Imaging LLC
Multiple therapeutic drugs/drugs of abuse IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Quidel Cardiovascular Inc.
Non-rechargeable public automated external defibrillator
Type: General Medical Device
Manufacturer: CU Medical Systems, Inc.
Cystic fibrosis IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Quantimetrix Corporation
Multiple-type clinical chemistry analyte profile IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Quantimetrix Corporation
Streptococcus pneumoniae antigen IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Quidel Corporation

