Argentina flag1716-261

Anti-HBs, Anti-HBc and Anti-HBc IgM are used as an aid in the diagnosis of Hepatitis B Virus (HBV) infection

Anti-HBs, Anti-HBc y Anti-HBc IgM se utilizan como ayuda en el diagnóstico de la infección por el Virus de la Hepatitis B (VHB)

Argentina Medical Device Registration · MAGLUMI · BERNARDO LEW E HIJOS SRL. · Registered July 19, 2024

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
1716-261
Brand Name
MAGLUMI
Product Name
Anti-HBs, Anti-HBc and Anti-HBc IgM are used as an aid in the diagnosis of Hepatitis B Virus (HBV) infection
Anti-HBs, Anti-HBc y Anti-HBc IgM se utilizan como ayuda en el diagnóstico de la infección por el Virus de la Hepatitis B (VHB)
Registration information
Registration Date
July 19, 2024
Database ID
cmhayu5bc0k6kekuzwdmlgi3z
Authorized representative
Documents
Product information

1.- MAGLUMI Anti-HBs (CLIA) 2.- Anti-HBc MAGLUMAS (CLIA) 3.- Anti-HBc IgM MAGLUMAS (CLIA) 4.- MAGLUMI Anti-HBs (CLIA) Controls 5.- MAGLUMI Anti-HBc (CLIA) Controls 6.- MAGLUMI Anti-HBc IgM (CLIA) Controls

Spanish:

1.- MAGLUMI Anti-HBs (CLIA) 2.- MAGLUMI Anti-HBc (CLIA) 3.- MAGLUMI Anti-HBc IgM (CLIA) 4.- MAGLUMI Anti-HBs (CLIA) Controls 5.- MAGLUMI Anti-HBc (CLIA) Controls 6.- MAGLUMI Anti-HBc IgM (CLIA) Controls

About this record

Access comprehensive regulatory information for Anti-HBs, Anti-HBc and Anti-HBc IgM are used as an aid in the diagnosis of Hepatitis B Virus (HBV) infection 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 July 19, 2024.

This page provides complete registration details including product code (1716-261), 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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