8428bb626ba09c4b97668c4a17110149

AMA 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
8428bb626ba09c4b97668c4a17110149
Registration date
February 08, 2021
Expiration date
February 08, 2026
Manufacturer
City
BARCELONA
Country
SPAIN
Address
COSTA BRAVA 30, BARCELONA 08030
Product owner
Name
BIOSYSTEMS S.A
Country
SPAIN
Authorized representative
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 ONE OR MULTIPLE MITOCHONDRIAL ANTIBODIES M2 (ANTI-MI2) IN A CLINICAL SPECIMEN

About this record

Access comprehensive regulatory information for AMA Positive Control in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 8428bb626ba09c4b97668c4a17110149 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.