Argentina flag1102-166

1) Hepatitis B Surface Antigen (CLIA); 2) HBsAg Positive Control; 3) HBsAg Negative Control; 4) HBsAg Calibrators

Argentina Medical Device Registration · Wiener lab. · WIENER Laboratories S.A.I.C. · Registered June 07, 2024

Agile modification of product registration for IVD diagnostics - Group C and D
Device classification
Registration Type
Agile modification of product registration for IVD diagnostics - Group C and D
Modificación Ágil De Registro De Productos Para Diagnóstico IVD - Grupo C Y D
Product Code
1102-166
Brand Name
Wiener lab.
Product Name
1) Hepatitis B Surface Antigen (CLIA); 2) HBsAg Positive Control; 3) HBsAg Negative Control; 4) HBsAg Calibrators
Registration information
Registration Date
June 07, 2024
Database ID
cmhaytq4f07paekuzfdy2a9p0
Authorized representative
Name
WIENER Laboratories S.A.I.C.
WIENER Laboratorios S.A.I.C.
Documents
About this record

Access comprehensive regulatory information for 1) Hepatitis B Surface Antigen (CLIA); 2) HBsAg Positive Control; 3) HBsAg Negative Control; 4) HBsAg Calibrators in the Argentina medical device market through Pure Global AI's free database. This Agile modification of product registration 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 (1102-166), 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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