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Immunoassay for the qualitative determination of hepatitis B surface antigen (HBsAg).

Inmunoensayo para la determinación cualitativa del antígeno de superficie de la hepatitis B (HBsAg).

Argentina Medical Device Registration · Elecsys · ROCHE S.A. PRODUCTS · Registered July 15, 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
740-588
Brand Name
Elecsys
Product Name
Immunoassay for the qualitative determination of hepatitis B surface antigen (HBsAg).
Inmunoensayo para la determinación cualitativa del antígeno de superficie de la hepatitis B (HBsAg).
Registration information
Registration Date
July 15, 2024
Database ID
cmhayu5bc0k90ekuznjf6oflw
Authorized representative
Name
ROCHE S.A. PRODUCTS
PRODUCTOS ROCHE S.A.
Product information

1) Elecsys HBsAg II (Ref. 07251076190); 2) Elecsys HBsAg II (Ref. 08814848190); 3) Elecsys HBsAg II (Ref. 08814856190); 4) Elecsys HBsAg II (Ref. 08814864190).

About this record

Access comprehensive regulatory information for Immunoassay for the qualitative determination of hepatitis B surface antigen (HBsAg). 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 July 15, 2024.

This page provides complete registration details including product code (740-588), 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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