United Kingdom MHRA device registration 148707

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Acro Biotech, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 148707
MHRA Reference Number: 148707
Date Registered: Nov 26, 2024
Last Updated: Apr 13, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Acro Biotech, Inc.
Address: 4650 Arrow Highway, Suite D-6
Montclair, CA, United States
Created Date: Apr 20, 2021

Authorized Representative

Name: Obelis UK Ltd
Relationship Type: UK Responsible Person
Address: Sandford Gate, East Point Business Park
Oxford , England, United Kingdom
Postcode: OX4 6LB

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About this record

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 148707. The device is manufactured by Acro Biotech, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Obelis UK Ltd.

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