Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated - UK MHRA Medical Device Registration
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 71425. The device is manufactured by Acon Laboratories, 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
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Type
IVD General
Date Registered
Mar 31, 2021
Last Updated
Oct 10, 2023
Address
5850 Oberlin Drive, #340
San Diego, CA, United States
Created Date
Mar 31, 2021
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.
Glucose IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Haemoglobin detection IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Urine analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Urine analyser IVD, point-of-care
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Ketone (acetoacetate) IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Coagulation factor II (prothrombin) IVD, kit, chromogenic
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Fluorescent immunoassay analyser IVD, point-of-care, line-powered
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Glucose IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Glucose monitoring system IVD, home-use
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Glucose monitoring system IVD, home-use
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Haemoglobin/hematocrit IVD, kit, electrometry
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
High density lipoprotein (HDL) cholesterol IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Ketone (acetoacetate) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Multiple clinical chemistry analyte monitoring system IVD, home-use
Type: In Vitro Diagnostic Device
Manufacturer: Acon Laboratories, Inc.
Blood lancet, single-use
Type: General Medical Device
Manufacturer: Acon Laboratories, Inc.

