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Immunological test for the quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma.

Test inmunológico para la determinación cuantitativa de la gonadotropina coriónica humana (hCG) en suero y plasma humanos.

Argentina Medical Device Registration · Elecsys · ROCHE S.A. PRODUCTS · Registered August 14, 2024

Non-agile modification of products for IVD diagnostics - Group C and D
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
740-8544
Brand Name
Elecsys
Product Name
Immunological test for the quantitative determination of human chorionic gonadotropin (hCG) in human serum and plasma.
Test inmunológico para la determinación cuantitativa de la gonadotropina coriónica humana (hCG) en suero y plasma humanos.
Registration information
Registration Date
August 14, 2024
Database ID
cmhaytq4a077fekuz1giyuv0e
Authorized representative
Name
ROCHE S.A. PRODUCTS
PRODUCTOS ROCHE S.A.
Product information

1) Elecsys HCG+ß (Catalogue number: 0725102190) 2) Elecsys free HCG+ß (Catalogue number: 07027303190)

Spanish:

1) Elecsys HCG+ß (N° de catálogo: 0725102190) 2) Elecsys free HCG+ß (N° de catálogo: 07027303190)

About this record

Access comprehensive regulatory information for Immunological test for the quantitative determination of human chorionic gonadotropin (hCG) 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 14, 2024.

This page provides complete registration details including product code (740-8544), 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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