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LIAISON® FPSA - COFEPRIS Registration 1241R2018 SSA

Access comprehensive regulatory information for LIAISON® FPSA (FPSA LINK®) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1241R2018 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on May 30, 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 II
1241R2018 SSA
LIAISON® FPSA
COFEPRIS Analysis ID: 1241R2018 SSA
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Product Use / Uso del Producto
Spanish

ENSAYO IN VITRO PARA DETERMINACIÓN CUANTITATIVA DE ANTÍGENO PROSTÁTICO ESPECÍFICO LIBRE (FPSA) EN SUERO O PLASMA HUMANOS (CON EDTA O HEPARINIZADO). LA PRUEBA DEBE REALIZARSE EN LA SERIE DE INSTRUMENTOS LIAISON® ANALYZER.

English

IN VITRO ASSAY FOR QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM OR PLASMA (WITH EDTA OR HEPARINIZED). THE TEST SHOULD BE PERFORMED ON THE LIAISON® ANALYZER INSTRUMENT SERIES.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
DETERMINACIÓN CUANTITATIVA DE ANTÍGENO PROSTÁTICO ESPECÍFICO LIBRE (FPSA) EN SUERO Y PLASMA HUMANOS.
Trade Name (English)
QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) IN HUMAN SERUM AND PLASMA.
Registration Information
Analysis ID
1241R2018 SSA
Registration Date
May 30, 2018
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.