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Electrochemiluminescence immunoassay "ECLIA" for the quantitative detection of total prostate-specific antigen (tPSA) in human serum and plasma. - Argentina Medical Device Registration

Access comprehensive regulatory information for Electrochemiluminescence immunoassay "ECLIA" for the quantitative detection of total prostate-specific antigen (tPSA) 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 August 09, 2024.

This page provides complete registration details including product code (740-738), 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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Non-agile modification of products for IVD diagnostics - Group C and D
Electrochemiluminescence immunoassay "ECLIA" for the quantitative detection of total prostate-specific antigen (tPSA) in human serum and plasma.
Inmunoensayo de electroquimioluminiscencia ”ECLIA” destinado a la detección cuantitativa del antígeno prostático específico total (tPSA) en suero y plasma humanos.
Argentina Medical Device Registration
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Product Information

1) Elecsys Total PSA (Cat N°: 8791686190); 2) Elecsys Total PSA (Cat N°: 8791716190); 3) Elecsys Total PSA (Cat N°: 8791732190); 4) Total PSA CalSet II (Cat N°: 8838534190).

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
740-738
Brand Name
Elecsys
Product Name
Electrochemiluminescence immunoassay "ECLIA" for the quantitative detection of total prostate-specific antigen (tPSA) in human serum and plasma.
Inmunoensayo de electroquimioluminiscencia ”ECLIA” destinado a la detección cuantitativa del antígeno prostático específico total (tPSA) en suero y plasma humanos.
Registration Information
Registration Date
August 09, 2024
Database ID
cmhayu5be0kemekuzn1abi70z
Authorized Representative
Name
ROCHE S.A. PRODUCTS
PRODUCTOS ROCHE S.A.