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The Free ß-HCG and PAPP-A assays are used to detect congenital disorders during the first trimester of pregnancy

Los ensayos Free ß-HCG y PAPP-A son utilizados para detectar trastornos congénitos durante el primer trimestre de embarazo

Argentina Medical Device Registration · MAGLUMI · BERNARDO LEW E HIJOS SRL. · Registered December 21, 2023

Registration of products for IVD diagnostics - Group C and D
Device classification
Registration Type
Registration of products for IVD diagnostics - Group C and D
Registro De Productos Para Diagnóstico IVD - Grupo C Y D
Product Code
1716-260
Brand Name
MAGLUMI
Product Name
The Free ß-HCG and PAPP-A assays are used to detect congenital disorders during the first trimester of pregnancy
Los ensayos Free ß-HCG y PAPP-A son utilizados para detectar trastornos congénitos durante el primer trimestre de embarazo
Registration information
Registration Date
December 21, 2023
Database ID
cmhaytwgl0btqekuz7euyhbwg
Authorized representative
Documents
Product information

1- MAGLUMI Free ß-HCG (CLIA) 2- MAGLUMI PAPP-A (CLIA) 3- MAGLUMI Free ß-HCG (CLIA) Controls 4- MAGLUMI PAPP-A (CLIA) Controls

Spanish:

1- MAGLUMI Free ß-HCG (CLIA) 2- MAGLUMI PAPP-A (CLIA) 3- MAGLUMI Free ß-HCG (CLIA) Controls 4- MAGLUMI PAPP-A (CLIA) Controls

About this record

Access comprehensive regulatory information for The Free ß-HCG and PAPP-A assays are used to detect congenital disorders during the first trimester of pregnancy 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 December 21, 2023.

This page provides complete registration details including product code (1716-260), brand name (MAGLUMI), 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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