Isothermal nucleic acid amplification analyser IVD, laboratory, automated - UK MHRA Medical Device Registration
Isothermal nucleic acid amplification analyser IVD, laboratory, automated is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 106153. The device is manufactured by Hologic, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Hologic 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
Isothermal nucleic acid amplification analyser IVD, laboratory, automated
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Jun 20, 2024
Name
Hologic, Inc.Address
10210 Genetic Center Drive
San Diego, CA, United States
Created Date
Nov 6, 2017
Name
Hologic Ltd.Relationship Type
Address
Heron House 6 The Oaks Business Park Crewe Road Wythenshawe
Manchester, Lancashire, England, United Kingdom
Postcode: M23 9HZ
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.
Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Mar 6, 2025
Mammographic stereotactic biopsy system
Type: General Medical Device
Registered: Jan 7, 2025
Buffered sample diluent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cytomegalovirus (CMV) nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cytomegalovirus (CMV) nucleic acid IVD, reagent
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Exogenous DNA/RNA internal control IVD, kit
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
General specimen collection kit IVD, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Fibronectin IVD, kit, enzyme immunohistochemistry
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
General specimen collection kit IVD, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered sample diluent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cytomegalovirus (CMV) nucleic acid IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Buffered sample diluent IVD, automated/semi-automated system
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Cytomegalovirus (CMV) nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.
Fibronectin IVD, kit, enzyme immunohistochemistry
Type: In Vitro Diagnostic Device
Manufacturer: Hologic, Inc.

