Ethyl glucuronide (EtG) IVD, calibrator - UK MHRA Medical Device Registration

Ethyl glucuronide (EtG) IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 110907. The device is manufactured by Immunalysis Corporation from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Ethyl glucuronide (EtG) IVD, calibrator

MHRA Device ID: 110907•Ref: 110907

Device Type

In Vitro Diagnostic Device

Devices

Ethyl glucuronide (EtG) IVD, calibrator

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

Immunalysis Corporation

Address

829 Towne Center Drive

Pomona, California, United States

Created Date

Oct 5, 2021

Authorized Representative

Name

Unipath Limited (trading as Alere International)

Relationship Type

UK Responsible Person

Address

Abbott House Vanwall Road Vanwall Business Park

Maidenhead, Windsor And Maidenhead, England, United Kingdom

Postcode: SL6 4XE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Immunalysis Corporation (10)

Other Products from Same Authorized Representative (10)

Ethyl glucuronide (EtG) IVD, calibrator - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

6-Acetyl morphine IVD, calibrator

6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Buprenorphine IVD, control

Buprenorphine IVD, kit, enzyme immunoassay (EIA)

Cannabinoid/cannabinoid metabolite IVD, control

Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)

Fentanyl IVD, kit, enzyme immunoassay (EIA)

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control

Amphetamine-specific IVD, control

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Barbiturate IVD, kit, enzyme immunoassay (EIA)

Buprenorphine IVD, calibrator

Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Fentanyl IVD, calibrator

Fentanyl IVD, control

Ketamine/ketamine metabolite IVD, calibrator

Multiple antidepressant therapeutic drug monitoring IVD, reagent