D-dimer IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
D-dimer IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125097. The device is manufactured by Princeton BioMeditech Corporation from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting 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
D-dimer IVD, kit, rapid ICT, clinical
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Sep 28, 2024
Address
4242 US Highway 1
Monmouth Junction, New Jersey, United States
Created Date
Dec 21, 2021
Relationship Type
Address
Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP
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.
Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Faecal occult blood IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Methamphetamine-specific IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Photometric/spectroscopic immunoassay analyser IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cannabinoid/cannabinoid metabolite 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
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Amphetamine-specific 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
Laparoscopic motorized instrument control unit
Type: General Medical Device
Manufacturer: American Orthodontics Corp
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Sugentech, Inc.
Ophthalmic fundus camera
Type: General Medical Device
Manufacturer: Forus Health Pvt. Ltd.
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Sugentech, Inc.
Cryolipolysis body contouring system gel pad
Type: General Medical Device
Manufacturer: CLASSYS Inc.
Ultrasonic hyperthermia system
Type: General Medical Device
Manufacturer: CLASSYS Inc.
Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Sugentech, Inc.
Breathing circuit bag, single-use
Type: General Medical Device
Manufacturer: AirLife Finland Oy
Breathing circuit catheter mount, single-use
Type: General Medical Device
Manufacturer: AirLife Finland Oy
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Sugentech, Inc.

