United Kingdom MHRA device registration 88978

Immunoassay reagent vehicle tray IVD, reusable

United Kingdom·In Vitro Diagnostic Device·Abbott Diagnostics Scarborough, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 88978
MHRA Reference Number: 88978
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Immunoassay reagent vehicle tray IVD, reusable
Type: IVD General

Manufacturer

Name: Abbott Diagnostics Scarborough, Inc.
Address: 10 Southgate Rd
Scarborough, Maine, United States
Created Date: Jul 2, 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

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 Abbott Diagnostics Scarborough, Inc.

Additional devices registered by the same manufacturer

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 88965

General specimen collection kit IVD, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 181954

Isothermal nucleic acid amplification analyser IVD, laboratoryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 162231

Legionella pneumophila antigen IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 88351

Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 88970

Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 88352

Photometric/spectroscopic immunoassay analyser IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 88959

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 87389

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kitNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 88960

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

Type: In Vitro Diagnostic Device

Device ID: 88964

Other products from same authorized representative

Additional devices represented by Unipath Limited (trading as Alere International) in the UK

Capillary blood collection tube IVD, K2EDTANov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 92421

Capillary blood collection tube IVD, K2EDTANov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 164998

Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 180041

HIV1/HIV2 antigen/antibody IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 73845

HIV1/HIV2 antigen/antibody IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 184990

HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 192217

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 92419

Capillary blood collection tube IVD, no additiveNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Technologies AS

Device ID: 89819

Glycated haemoglobin (HbA1c) IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Technologies AS

Device ID: 189010

Buffered isotonic saline reagent IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Diagnostics Medical Co., Ltd.

Device ID: 92422

About this record

Immunoassay reagent vehicle tray IVD, reusable is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 88978. The device is manufactured by Abbott Diagnostics Scarborough, 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device