United Kingdom MHRA device registration 205645

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Diesse Diagnostica Senese Spa·Registered Nov 26, 2024

Registration details

Device ID: 205645
MHRA Reference Number: 205645
Date Registered: Nov 26, 2024
Last Updated: Oct 25, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
Type: Class B

Manufacturer

Name: Diesse Diagnostica Senese Spa
Address: Diesse Diagnostica Senese Spa Viale Decumano 36
Milan, Italy
Created Date: Jul 8, 2021

Authorized Representative

Name: IVDeology UKRP Ltd
Relationship Type: UK Responsible Person
Address: Maidstone Innovation Centre Gidds Pond Way
Maidstone, Kent, England, United Kingdom
Postcode: ME14 5FY

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About this record

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 205645. The device is manufactured by Diesse Diagnostica Senese Spa from Italy, classified as In Vitro Diagnostic Device. The authorized representative in the UK is IVDeology UKRP Ltd.

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