United Kingdom MHRA device registration 87965

Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)

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

Registration details

Device ID: 87965
MHRA Reference Number: 87965
Date Registered: Nov 26, 2024
Last Updated: Apr 13, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)
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

Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 87965. 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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