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Chemiluminescent immunoassay for simultaneous detection of HIV p24 antigen and HIV-1 or HIV-2 antibodies

Inmunoensayo quimioluminiscente para la detección simultánea del antígeno p24 del HIV y los anticuerpos del HIV-1 o HIV-2

Argentina Medical Device Registration · Wiener lab. · WIENER Laboratories S.A.I.C. · Registered April 29, 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
1102-171
Brand Name
Wiener lab.
Product Name
Chemiluminescent immunoassay for simultaneous detection of HIV p24 antigen and HIV-1 or HIV-2 antibodies
Inmunoensayo quimioluminiscente para la detección simultánea del antígeno p24 del HIV y los anticuerpos del HIV-1 o HIV-2
Registration information
Registration Date
April 29, 2024
Database ID
cmhayu0e30ewqekuzz30acwah
Authorized representative
Name
WIENER Laboratories S.A.I.C.
WIENER Laboratorios S.A.I.C.
Documents
Product information

. 1) Antigen and Antibodies to Human Immunodeficiency Virus (CLIA) 2) HIV Ag/Ab Positive Control 3) HIV Ag/Ab Negative Control 4) HIV Calibrators

About this record

Access comprehensive regulatory information for Chemiluminescent immunoassay for simultaneous detection of HIV p24 antigen and HIV-1 or HIV-2 antibodies 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 April 29, 2024.

This page provides complete registration details including product code (1102-171), 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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