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Chemiluminescent immunoassay (CLIA) for the quantitative determination of tumour markers - Argentina Medical Device Registration

Access comprehensive regulatory information for Chemiluminescent immunoassay (CLIA) for the quantitative determination of tumour markers in the Argentina medical device market through Pure Global AI's free database. This Registration 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 June 07, 2024.

This page provides complete registration details including product code (1102-231), brand name (Wiener lab.), 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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Registration of products for IVD diagnostics - Group C and D
Chemiluminescent immunoassay (CLIA) for the quantitative determination of tumour markers
Inmunoensayo quimioluminiscente (CLIA) para la determinaciรณn cuantitativa de marcadores tumorales
Argentina Medical Device Registration
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Product Information

1) Carbohydrate Antigen 50 (CLIA) 2) CA50 Calibrators 3) Carbohydrate Antigen 242 (CLIA) 4) CA242 Calibrators 5) Human Epididymal Protein 4 (CLIA) 6) HE4 Calibrators 7) Tumor Marker Control II

Device Classification
Registration Type
Registration of products for IVD diagnostics - Group C and D
Registro De Productos Para Diagnรณstico IVD - Grupo C Y D
Product Code
1102-231
Brand Name
Wiener lab.
Product Name
Chemiluminescent immunoassay (CLIA) for the quantitative determination of tumour markers
Inmunoensayo quimioluminiscente (CLIA) para la determinaciรณn cuantitativa de marcadores tumorales
Registration Information
Registration Date
June 07, 2024
Database ID
cmhayu6cs0kv3ekuzb7fx10vf
Documents
Authorized Representative
Name
WIENER Laboratories S.A.I.C.
WIENER Laboratorios S.A.I.C.