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In vitro immunoassay for the quantitative determination of CA 15-3 antigen in human serum and plasma. - Argentina Medical Device Registration

Access comprehensive regulatory information for In vitro immunoassay for the quantitative determination of CA 15-3 antigen in human serum and plasma. in the Argentina medical device market through Pure Global AI's free database. This Non-agile modification of products for IVD diagnostics - Group C and D medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on July 15, 2024.

This page provides complete registration details including product code (740-554), brand name (Elecsys), authorized representative information, registration type, and regulatory compliance data from the official Argentina ANMAT medical device database. Pure Global AI offers free access to Argentina's medical device registry, helping global MedTech companies navigate Argentina regulations efficiently.

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Argentina ANMAT Data
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Non-agile modification of products for IVD diagnostics - Group C and D
In vitro immunoassay for the quantitative determination of CA 15-3 antigen in human serum and plasma.
Inmunoensayo in vitro para la determinación cuantitativa del antígeno CA 15-3 en suero y plasma humanos .
Argentina Medical Device Registration
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Product Information

Elecsys CA 15-3 II (Catalogue No.: 07027001190).

Spanish:

Elecsys CA 15-3 II (N° de catálogo: 07027001190).

Device Classification
Registration Type
Non-agile modification of products for IVD diagnostics - Group C and D
Modificación NO Ágil De Productos Para Diagnóstico IVD - Grupo C Y D
Product Code
740-554
Brand Name
Elecsys
Product Name
In vitro immunoassay for the quantitative determination of CA 15-3 antigen in human serum and plasma.
Inmunoensayo in vitro para la determinación cuantitativa del antígeno CA 15-3 en suero y plasma humanos .
Registration Information
Registration Date
July 15, 2024
Database ID
cmhayu5bc0k9bekuzopzmqf0w
Authorized Representative
Name
ROCHE S.A. PRODUCTS
PRODUCTOS ROCHE S.A.