United Kingdom MHRA device registration 117844

Dried blood spot collection kit IVD

United Kingdom·In Vitro Diagnostic Device·ZRT Laboratory·Registered Oct 29, 2024

Registration details

Device ID: 117844
MHRA Reference Number: 117844
Date Registered: Oct 29, 2024
Last Updated: Sep 26, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Dried blood spot collection kit IVD
Type: IVD General

Manufacturer

Name: ZRT Laboratory
Address: 8605 SW Creekside Place
Beaverton, OR, United States
Created Date: Dec 7, 2021

Authorized Representative

Name: Obelis UK Ltd
Relationship Type: UK Responsible Person
Address: Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB

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 ZRT Laboratory

Additional devices registered by the same manufacturer

General specimen container IVD, no additive/mediumOct 29, 2024

Type: In Vitro Diagnostic Device

Device ID: 117842

Non-evacuated urine specimen container IVD, no additiveOct 29, 2024

Type: In Vitro Diagnostic Device

Device ID: 117843

Other products from same authorized representative

Additional devices represented by Obelis UK Ltd in the UK

Total cortisol IVD, reagent

Type: In Vitro Diagnostic Device

Manufacturer: Boditech Med Inc.

Device ID: 176536

Prothrombin time (PT) IVD, reagent

Type: In Vitro Diagnostic Device

Manufacturer: Universal Biosensors Pty Ltd

Device ID: 176104

Invasive medical device leak tester, mechanicalNov 26, 2024

Type: System or Procedure Pack

Manufacturer: Gynesonics Inc.

Device ID: 139426

Sterilization packaging, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Gynesonics Inc.

Device ID: 95142

Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrodeNov 26, 2024

Type: General Medical Device

Manufacturer: Gynesonics Inc.

Device ID: 95137

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: Gynesonics Inc.

Device ID: 114806

Carbide dental bur, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: MDT Micro Diamond Technologies Ltd.

Device ID: 107263

Carbide dental bur, reusableNov 26, 2024

Type: General Medical Device

Manufacturer: MDT Micro Diamond Technologies Ltd.

Device ID: 200565

Dental abrasive point, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: MDT Micro Diamond Technologies Ltd.

Device ID: 107266

Sterilization packaging, single-useNov 26, 2024

Type: General Medical Device

Manufacturer: Gynesonics Inc.

Device ID: 144724

About this record

Dried blood spot collection kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 117844. The device is manufactured by ZRT Laboratory from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Obelis UK 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.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device