LIAISON® CA 15-3® - COFEPRIS Registration 1967R2019 SSA
Access comprehensive regulatory information for LIAISON® CA 15-3® (AC 15-3® 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 1967R2019 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on October 10, 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.
ENSAYO IN VITRO PARA LA DETERMINACIÓN CUANTITATIVA DEL ANTÍGENO CA 15-3® EN SUERO HUMANO Y PLASMA CON EDTA O HEPARINIZADO DURANTE EL SEGUIMIENTO DE PACIENTES CON CÁNCER DE MAMA. EL ENSAYO DEBE REALIZARSE EN LA SERIE DE INSTRUMENTOS LIAISON® ANALYZER.
IN VITRO ASSAY FOR THE QUANTITATIVE DETERMINATION OF CA 15-3® ANTIGEN IN HUMAN SERUM AND PLASMA WITH EDTA OR HEPARINIZED DURING THE FOLLOW-UP OF PATIENTS WITH BREAST CANCER. THE TEST SHOULD BE PERFORMED ON THE LIAISON® ANALYZER INSTRUMENT SERIES.