United Kingdom MHRA device registration 114099

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·GenMark Diagnostics·Registered Nov 26, 2024

Registration details

Device ID: 114099
MHRA Reference Number: 114099
Date Registered: Nov 26, 2024
Last Updated: Apr 17, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: GenMark Diagnostics
Address: 5964 La Place Ct
CARLSBAD, California, United States
Created Date: Nov 19, 2021

Authorized Representative

Name: Emergo Consulting (UK) Limited
Relationship Type: UK Responsible Person
Address: Compass House, Vision Park Histon c/o Cr360 – UL International
Cambridge, England, United Kingdom
Postcode: CB24 9BZ

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 GenMark Diagnostics

Additional devices registered by the same manufacturer

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 183361

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 183362

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114102

Multiple respiratory virus antigen IVD, kit, multiplexNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114100

Multiple-genus respiratory virus antigen IVD, kit, multiplexNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 183360

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 183359

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114101

Other products from same authorized representative

Additional devices represented by Emergo Consulting (UK) Limited in the UK

External orthopaedic fixation system, reusable

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 101838

External orthopaedic fixation system, single-use

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 78955

Bone nail guidewire, reusable

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127342

External orthopaedic fixation system, reusable

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127361

External orthopaedic fixation system, single-use

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 113172

External orthopaedic fixation system, single-use

Type: System or Procedure Pack

Manufacturer: Orthofix S.r.l.

Device ID: 160344

Bone nail driver

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 113158

Bone nail end-cap

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 78960

External orthopaedic fixation frame calculation software

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 113166

External orthopaedic fixation system, single-use

Type: General Medical Device

Manufacturer: Orthofix S.r.l.

Device ID: 127343

About this record

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 114099. The device is manufactured by GenMark Diagnostics from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) 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