740-738Electrochemiluminescence immunoassay "ECLIA" for the quantitative detection of total prostate-specific antigen (tPSA) in human serum and plasma.
Argentina Medical Device Registration · Elecsys · ROCHE S.A. PRODUCTS · Registered August 09, 2024
Non-agile modification of products for IVD diagnostics - Group C and D- 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 Date
- August 09, 2024
- Database ID
- cmhayu5be0kemekuzn1abi70z
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).
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.