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ed2e8ce59504c646e9906db4c7015e6e

ATA Positive Control

BIOSYSTEMS S.A·III·Ecuador ARCSA·Registered February 08, 2021
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
BIOSYSTEMS
Commercial name
19-173 IVD Reagents/Kits, Immunoassay, Autoimmune
Registration information
Analysis ID
ed2e8ce59504c646e9906db4c7015e6e
Registration date
February 08, 2021
Expiration date
February 08, 2026
Manufacturer
Name
BIOSYSTEMS S.A
City
BARCELONA
Country
SPAIN
Address
COSTA BRAVA 30, BARCELONA 08030
Product owner
Name
BIOSYSTEMS S.A
Country
SPAIN
Authorized representative
Name
MCG DIAGNOSTICA S.A.
Address
CALLE CUENCA 102 AND ELOY ALFARO
Phone
42402419
Product use

A MATERIAL USED TO VERIFY THE PERFORMANCE OF AN ASSAY INTENDED TO BE USED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO THYROID PEROXIDASE (ANTI-TPO); ALSO KNOWN AS ANTI-MITOCHON ANTIBODY, IN A CLINICAL SAMPLE

About this record

Access comprehensive regulatory information for ATA Positive Control in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID ed2e8ce59504c646e9906db4c7015e6e and manufactured by BIOSYSTEMS S.A. The device was registered on February 08, 2021.

This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.