United Kingdom MHRA device registration 125573

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassay

United Kingdom·In Vitro Diagnostic Device·INOVA Diagnostics ·Registered Nov 26, 2024

Registration details

Device ID: 125573
MHRA Reference Number: 125573
Date Registered: Nov 26, 2024
Last Updated: Nov 22, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassay
Type: IVD General

Manufacturer

Name: INOVA Diagnostics
Address: 9900 Old Grove Road
San Diego, United States
Created Date: Dec 21, 2021

Authorized Representative

Name: Werfen Ltd
Relationship Type: UK Responsible Person
Address: 712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester
Manchester, England, United Kingdom
Postcode: WA3 6DE

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About this record

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125573. The device is manufactured by INOVA Diagnostics from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen Ltd.

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