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LIAISON® CA 19-9 - COFEPRIS Registration 1863R2019 SSA

Access comprehensive regulatory information for LIAISON® CA 19-9 (CA 19-9 LINK®) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1863R2019 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on September 13, 2019.

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
1863R2019 SSA
LIAISON® CA 19-9
COFEPRIS Analysis ID: 1863R2019 SSA
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Product Use / Uso del Producto
Spanish

PARA LA DETERMINACIÓN CUANTITATIVA DEL ANTÍGENO CA 19-9 EN SUERO HUMANO Y PLASMA HUMANO CON EDTA O CITRATADO DURANTE EL SEGUIMIENTO DE PACIENTES CON TUMORES GASTROINTESTINALES. EL ENSAYO DEBE REALIZARSE EN LA SERIE DE INSTRUMENTOS LIAISON® ANALYZER.

English

FOR THE QUANTITATIVE DETERMINATION OF CA 19-9 ANTIGEN IN HUMAN SERUM AND HUMAN PLASMA WITH EDTA OR CITRATE DURING THE FOLLOW-UP OF PATIENTS WITH GASTROINTESTINAL TUMORS. THE TEST SHOULD BE PERFORMED ON THE LIAISON® ANALYZER INSTRUMENT SERIES.

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)
REACTIVO PARA LA DETERMINACIÓN DEL ANTÍGENO CA 19-9
Trade Name (English)
REAGENT FOR THE DETERMINATION OF ANTIGEN CA 19-9
Registration Information
Analysis ID
1863R2019 SSA
Registration Date
September 13, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.