United Kingdom MHRA device registration 88966

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

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

Registration details

Device ID: 88966
MHRA Reference Number: 88966
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
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

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About this record

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 88966. 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).

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