Thermal cycler nucleic acid amplification analyser IVD, point-of-care - UK MHRA Medical Device Registration
Thermal cycler nucleic acid amplification analyser IVD, point-of-care is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 175306. The device is manufactured by Credo Diagnostics Biomedical Pte. Ltd. Taiwan branch from Taiwan, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Advena 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
Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Nov 8, 2024
Address
(Building D) 15F., No.93, Sec.1, Xintai 5th Road
New taipei city , Xizhi District, Taiwan
Created Date
Aug 31, 2021
Name
Advena LtdRelationship Type
Address
Pure Offices Plato Close
Warwick, England, United Kingdom
Postcode: CV34 6WE
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.
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
SARS-CoV-2 nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Influenza A/B virus nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Respiratory syncytial virus (RSV) nucleic acid IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple drugs of abuse IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Biochemical Diagnostics, Inc
General-purpose syringe/needle
Type: General Medical Device
Manufacturer: PENTAFERTE ITALIA s.r.l.
General-purpose syringe, single-use
Type: General Medical Device
Manufacturer: PENTAFERTE ITALIA s.r.l.
ENFit oral/enteral syringe, single-use
Type: General Medical Device
Manufacturer: PENTAFERTE ITALIA s.r.l.
Stopcock
Type: General Medical Device
Manufacturer: PENTAFERTE ITALIA s.r.l.
Ethyl glucuronide (EtG) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Biochemical Diagnostics, Inc
Human chorionic gonadotropin beta-core fragment IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Biochemical Diagnostics, Inc
Nasogastric feeding tube
Type: General Medical Device
Manufacturer: PENTAFERTE ITALIA s.r.l.
Oral/enteral syringe drawing-up straw
Type: General Medical Device
Manufacturer: PENTAFERTE ITALIA s.r.l.
Medicine cup, single-use
Type: General Medical Device
Manufacturer: Hammarplast Medical AB

