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PSA ELISA - COFEPRIS Registration 522R2018 SSA

Access comprehensive regulatory information for PSA ELISA (PSA ELISA) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 522R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on February 23, 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
522R2018 SSA
PSA ELISA
COFEPRIS Analysis ID: 522R2018 SSA
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Product Use / Uso del Producto
Spanish

ANÁLISIS ELISA PARA LA DETERMINACIÓN CUANTITATIVA DEL ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) TOTAL EN SUERO HUMANO. EL ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) ES UNA GLICOPROTEÍNA (SERINA PROTEASA), SINTETIZADA POR LAS CÉLULAS EPITELIALES PROSTÁTICAS. LOS V

English

ELISA ANALYSIS FOR THE QUANTITATIVE DETERMINATION OF TOTAL PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. PROSTATE-SPECIFIC ANTIGEN (PSA) IS A GLYCOPROTEIN (SERINE PROTEASE), SYNTHESIZED BY PROSTATIC EPITHELIAL CELLS. THE V

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)
REACTIVOS PARA DETERMINAR ANTÍGENO PROSTÁTICO ESPECÍFICO
Trade Name (English)
REAGENTS TO DETERMINE PROSTATE-SPECIFIC ANTIGEN
Registration Information
Analysis ID
522R2018 SSA
Registration Date
February 23, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.