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Electrochemiluminescence immunoassay "ECLIA" for the quantitative determination of a1-fetoprotein in human serum and plasma.

Inmunoensayo de Electroquimioluminiscencia "ECLIA" para la determinación cuantitativa de la a1-fetoproteína en suero y plasma humanos.

Argentina Medical Device Registration · Elecsys · ROCHE S.A. PRODUCTS · Registered August 08, 2024

Agile modification of product registration for IVD diagnostics - Group C and D
Device classification
Registration Type
Agile modification of product registration for IVD diagnostics - Group C and D
Modificación Ágil De Registro De Productos Para Diagnóstico IVD - Grupo C Y D
Product Code
740-8563
Brand Name
Elecsys
Product Name
Electrochemiluminescence immunoassay "ECLIA" for the quantitative determination of a1-fetoprotein in human serum and plasma.
Inmunoensayo de Electroquimioluminiscencia "ECLIA" para la determinación cuantitativa de la a1-fetoproteína en suero y plasma humanos.
Registration information
Registration Date
August 08, 2024
Database ID
cmhaytq4b079jekuzttcj6adj
Authorized representative
Name
ROCHE S.A. PRODUCTS
PRODUCTOS ROCHE S.A.
Documents
About this record

Access comprehensive regulatory information for Electrochemiluminescence immunoassay "ECLIA" for the quantitative determination of a1-fetoprotein in human serum and plasma. in the Argentina medical device market through Pure Global AI's free database. This Agile modification of product registration 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 August 08, 2024.

This page provides complete registration details including product code (740-8563), 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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