United Kingdom MHRA device registration 144695

Multiple respiratory virus nucleic acid IVD, control

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Exact Diagnostics LLC·Registered Nov 26, 2024
Registration details
Device ID
144695
MHRA Reference Number
144695
Date Registered
Nov 26, 2024
Last Updated
Apr 16, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Multiple respiratory virus nucleic acid IVD, control
Type
IVD General
Manufacturer
Address
Exact Diagnostics LLC 100 South Jones Street Suite 100
Fort Worth, Texas, United States
Created Date
Apr 14, 2022
Authorized Representative
Relationship Type
UK Responsible Person
Address
The Junction 3rd And 4th Floor, Station Road, Watford, United Kingdom, WD17 1ET
WATFORD, Hertfordshire, England, United Kingdom
Postcode: wd17 1et
Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176179
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176185
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175386
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176184
C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176164
Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176139
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175389
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175394
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175395
D-dimer IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176162
Other products from Exact Diagnostics LLC

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by BIO-RAD LABORATORIES LIMITED in the UK

Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories Seattle Operations Redmond
Device ID: 129880
Multiple antinuclear antibody (ANA) screening IVD, reagentNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories Seattle Operations Redmond
Device ID: 129883
Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Device ID: 129342
Cyclic citrullinated peptide antibody (anti-CCP) IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Device ID: 129343
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplexNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Device ID: 129341
Microscope slide coverslip IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Device ID: 134443
Multiple Coeliac disease-associated antibody IVD, kit, multiplexNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Device ID: 129336
Multiple liver disease-associated antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Device ID: 129353
Multiple liver disease-associated antibody IVD, kit, fluorescent immunoassayNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories, Inc., Clinical Immunology Division (CID)
Device ID: 129354
Acid phosphatase isoenzyme IVD, reagentNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Bio-Rad Laboratories Seattle Operations Redmond
Device ID: 139144
About this record

Multiple respiratory virus nucleic acid IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 144695. The device is manufactured by Exact Diagnostics LLC from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is BIO-RAD LABORATORIES 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.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device