United Kingdom MHRA device registration 124660

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Abacus Diagnostica·Registered Dec 20, 2021

Registration details

Device ID: 124660
MHRA Reference Number: 124660
Date Registered: Dec 20, 2021
Last Updated: Dec 12, 2022

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: Abacus Diagnostica
Address: Tykistökatu 4D
Turku, Finland
Created Date: Dec 20, 2021

Authorized Representative

Name: Launch Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Ash House Ash Road New Ash Green
Longfield, Kent, United Kingdom
Postcode: DA3 8JD

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About this record

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 124660. The device is manufactured by Abacus Diagnostica from Finland, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

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