Optical laboratory instrument performance standard calibrator/control IVD, reusable - UK MHRA Medical Device Registration

Optical laboratory instrument performance standard calibrator/control IVD, reusable is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 87727. The device is manufactured by Alere San Diego, Inc. 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

🇬🇧

Optical laboratory instrument performance standard calibrator/control IVD, reusable

MHRA Device ID: 87727•Ref: 87727

Device Type

In Vitro Diagnostic Device

Devices

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

Alere San Diego, Inc.

Address

9942 Mesa Rim Road

San Diego, California, United States

Created Date

Jul 6, 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 Alere San Diego, Inc. (10)

Other Products from Same Authorized Representative (10)

Optical laboratory instrument performance standard calibrator/control IVD, reusable - 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

Capillary blood transfer tube IVD, heparin

Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

Mechanical micropipette IVD

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Photometric/spectroscopic immunoassay analyser IVD

Pipette tip IVD

Multiple-type clinical chemistry analyte profile IVD, control

Photometric/spectroscopic immunoassay analyser IVD

Capillary blood transfer tube IVD, heparin

Multiple lipid analyte IVD, reagent

Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

Mechanical micropipette IVD

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Photometric/spectroscopic immunoassay analyser IVD

Pipette tip IVD

Dengue virus antigen IVD, kit, rapid ICT, clinical

Dengue virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical

Capillary blood transfer tube IVD, heparin