United Kingdom MHRA device registration 167411

Isothermal nucleic acid amplification analyser IVD, point-of-care

United Kingdom·In Vitro Diagnostic Device·ZIP Diagnostics Pty Ltd·Registered Nov 22, 2024

Registration details

Device ID: 167411
MHRA Reference Number: 167411
Date Registered: Nov 22, 2024
Last Updated: Jan 10, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Isothermal nucleic acid amplification analyser IVD, point-of-care
Type: Class A

Manufacturer

Name: ZIP Diagnostics Pty Ltd
Address: 24 Cromwell Street,
Victoria, Collingwood , Australia
Created Date: Feb 28, 2023

Authorized Representative

Name: MDSS-UK RP LIMITED
Relationship Type: UK Responsible Person
Address: 6 Wilmslow Road, Rusholme
Manchester, England, United Kingdom
Postcode: M14 5TP

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 same authorized representative

Additional devices represented by MDSS-UK RP LIMITED in the UK

Fluorescent immunoassay analyser IVD, point-of-care, battery-poweredNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Corporation

Device ID: 138163

Clostridium difficile antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Corporation

Device ID: 159117

Multiple urine analyte IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quantimetrix Corporation

Device ID: 129748

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Cardiovascular Inc.

Device ID: 140265

Fluorescent immunoassay analyser IVD, point-of-care, battery-poweredNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Cardiovascular Inc.

Device ID: 147133

Multiple cardiac marker IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Cardiovascular Inc.

Device ID: 147132

Troponin I IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Cardiovascular Inc.

Device ID: 147126

Troponin I IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Cardiovascular Inc.

Device ID: 147125

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Corporation

Device ID: 138703

Influenza A virus antigen IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Quidel Corporation

Device ID: 138166

About this record

Isothermal 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 167411. The device is manufactured by ZIP Diagnostics Pty Ltd from Australia, 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.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device