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Chemiluminescent immunoassays (CLIA) for use in the iFlash automated analyzer for detection of respiratory disease antibodies in human serum and plasma

Inmunoensayos quimioluminiscentes (CLIA) para ser utilizados en el analizador automatizado iFlash para detección de anticuerpos de enfermedades respiratorias en suero y plasma humano

Argentina Medical Device Registration · YHLO · BIOARS S.A. · Registered August 06, 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
1127-387
Brand Name
YHLO
Product Name
Chemiluminescent immunoassays (CLIA) for use in the iFlash automated analyzer for detection of respiratory disease antibodies in human serum and plasma
Inmunoensayos quimioluminiscentes (CLIA) para ser utilizados en el analizador automatizado iFlash para detección de anticuerpos de enfermedades respiratorias en suero y plasma humano
Registration information
Registration Date
August 06, 2024
Database ID
cmhayu5be0kflekuzh5k4aahz
Authorized representative
Product information

1) iFlash-Mycoplasma pn. IgG 2) iFlash-Mycoplasma pn. IgM 3) iFlash-Chlamydia pn. IgG 4) iFlash-Chlamydia pn. IgM 5) iFlash-EB VCA IgG 6) iFlash-EB VCA IgM 7) iFlash-EB VCA IgA 8) iFlash-EB NA IgG 9) iFlash-EB NA IgA 10) iFlash-EB EA IgM

About this record

Access comprehensive regulatory information for Chemiluminescent immunoassays (CLIA) for use in the iFlash automated analyzer for detection of respiratory disease antibodies in human serum and plasma 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 August 06, 2024.

This page provides complete registration details including product code (1127-387), brand name (YHLO), 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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