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LIAISON® ANDROSTENEDIONE - COFEPRIS Registration 1576R2018 SSA

Access comprehensive regulatory information for LIAISON® ANDROSTENEDIONE (LIAISON® ANDROSTENEDIONE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1576R2018 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on June 15, 2018.

This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase I
1576R2018 SSA
LIAISON® ANDROSTENEDIONE
COFEPRIS Analysis ID: 1576R2018 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO DIASORIN LIAISON® ANDROSTENEDIONE ES UN INMUNOENSAYO QUIMIOLUMINISCENTE (CLIA) DE DIAGNÓSTICO IN VITRO INDICADO PARA LA DETERMINACIÓN CUANTITATIVA DE Δ4-ANDROSTENEDIONA EN SUERO HUMANO Y PLASMA CON EDTA. LOS RESULTADOS DEL ENSAYO DEBEN UTIL

English

THE DIASORIN LIAISON® ANDROSTENEDIONE ASSAY IS AN IN VITRO DIAGNOSTIC CHEMILUMINESCENT IMMUNOASSAY (CLIA) INDICATED FOR THE QUANTITATIVE DETERMINATION OF Δ4-ANDROSTENEDIONE IN HUMAN SERUM AND PLASMA WITH EDTA. THE RESULTS OF THE TEST SHOULD BE USEFUL

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
KIT PARA LA DETERMINACIÓN CUANTITATIVA DE Δ4-ANDROSTENEDIONA EN SUERO Y PLASMA.
Trade Name (English)
KIT FOR THE QUANTITATIVE DETERMINATION OF Δ4-ANDROSTENEDIONE IN SERUM AND PLASMA.
Registration Information
Analysis ID
1576R2018 SSA
Registration Date
June 15, 2018
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.