Multiple alcohol IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
Multiple alcohol IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 87958. The device is manufactured by Acro Biotech, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Obelis 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.
Device Type
In Vitro Diagnostic Device
Devices
Multiple alcohol IVD, kit, rapid ICT, clinical
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Apr 13, 2024
Address
4650 Arrow Highway, Suite D-6
Montclair, CA, United States
Created Date
Apr 20, 2021
Name
Obelis UK LtdRelationship Type
Address
Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB
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.
Alpha-fetoprotein (AFP) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Benzodiazepine group IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Calprotectin IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Carcinoembryonic antigen (CEA) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cotinine IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
D-dimer IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Total cortisol IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Boditech Med Inc.
Prothrombin time (PT) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Universal Biosensors Pty Ltd
Air-conduction tinnitus masker, out-of-ear
Type: General Medical Device
Manufacturer: audifon GmbH & Co. KG
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Type: General Medical Device
Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)
Nylon suture, non-bioabsorbable, monofilament
Type: General Medical Device
Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)
Nylon suture, non-bioabsorbable, multifilament
Type: General Medical Device
Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)
Orthopaedic bone screw, non-bioabsorbable, sterile
Type: General Medical Device
Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)
Orthopaedic bone nut
Type: General Medical Device
Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)
Orthopaedic bone washer, sterile
Type: General Medical Device
Manufacturer: Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)
Multi-purpose therapeutic saline solution
Type: General Medical Device
Manufacturer: Aurena Laboratories AB

