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Chemiluminescent immunoassay for the detection of hepatitis B surface antigen (HBsAg).

Inmunoensayo quimioluminiscente para la detección del antígeno de superficie de la hepatitis B (HBsAg).

Argentina Medical Device Registration · Wiener lab. · WIENER Laboratories S.A.I.C. · 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
1102-166
Brand Name
Wiener lab.
Product Name
Chemiluminescent immunoassay for the detection of hepatitis B surface antigen (HBsAg).
Inmunoensayo quimioluminiscente para la detección del antígeno de superficie de la hepatitis B (HBsAg).
Registration information
Registration Date
December 21, 2023
Database ID
cmhayubdm0p5mekuzp30ibqsk
Authorized representative
Name
WIENER Laboratories S.A.I.C.
WIENER Laboratorios S.A.I.C.
Documents
Product information

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

About this record

Access comprehensive regulatory information for Chemiluminescent immunoassay for the detection of hepatitis B surface antigen (HBsAg). 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 (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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