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Quantitative chemiluminescent immunoassay for tumor markers - Argentina Medical Device Registration

Access comprehensive regulatory information for Quantitative chemiluminescent immunoassay for tumor markers 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 08, 2024.

This page provides complete registration details including product code (1074-771), brand name (Siemens/Siemens Healthineers), 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
Quantitative chemiluminescent immunoassay for tumor markers
Inmunoensayo quimioluminiscente cuantitativo para marcadores tumorales
Argentina Medical Device Registration
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Product Information

1.Atellica IM Prostate-Specific Antigen (PSA) , 2) Atellica IM Calibrator Q (CAL Q), 3) Atellica IM Free Prostate-Specific Antigen (fPSA), 4) Atellica IM Free Prostate-Specific Antigen Calibrator (fPSA CAL), 5) Atellica IM Com-plexed Prostate Specific Antigen (cPSA), 6) Atellica IM cPSA Pretreatment Reagent (cPSA PRE), 7) Atellica IM Complexed Prostate Specific Antigen Quality Control (cPSA QC), 8) Atellica IM Calibrator Y (CAL Y)

Device Classification
Registration Type
Non-agile modification of products for IVD diagnostics - Group C and D
Modificaciรณn NO รgil De Productos Para Diagnรณstico IVD - Grupo C Y D
Product Code
1074-771
Brand Name
Siemens/Siemens Healthineers
Product Name
Quantitative chemiluminescent immunoassay for tumor markers
Inmunoensayo quimioluminiscente cuantitativo para marcadores tumorales
Registration Information
Registration Date
August 08, 2024
Database ID
cmhaytq4b079hekuzaxnl4j3d
Authorized Representative