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MATERNAL SCREENING CONTROL LEVEL 1, 2 & 3 (MATERNAL CONTROL 1, 2 & 3) - COFEPRIS Registration 1884R2018 SSA

Access comprehensive regulatory information for MATERNAL SCREENING CONTROL LEVEL 1, 2 & 3 (MATERNAL CONTROL 1, 2 & 3) (MATERNAL SCREENING CONTROL LEVEL 1, 2 & 3 (MATERNAL CONTROL 1, 2 & 3)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1884R2018 SSA and manufactured by SOLUCIÓN INTEGRAL A SUS NECESIDADES REGULATORIAS, S.A. DE C.V.. The device was registered on August 03, 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
1884R2018 SSA
MATERNAL SCREENING CONTROL LEVEL 1, 2 & 3 (MATERNAL CONTROL 1, 2 & 3)
COFEPRIS Analysis ID: 1884R2018 SSA
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Product Use / Uso del Producto
Spanish

ESTE PRODUCTO ESTÁ DESTINADO PARA USO IN VITRO, EN EL CONTROL DE CALIDAD DE ALFA-FETOPROTEÍNA, HCG BETA LIBRE, ESTRIOL LIBRE, GONADOTROPINA CORIÓNICA HUMANA, INHIBINA A Y MÉTODOS PAPP-A EN SISTEMAS DE QUÍMICA CLÍNICA. AGENTE DE DIAGNÓSTICO IN VITRO. PAR

English

THIS PRODUCT IS INTENDED FOR IN VITRO USE, IN THE QUALITY CONTROL OF ALPHA-FETOPROTEIN, FREE BETA HCG, FREE ESTRIOL, HUMAN CHORIONIC GONADOTROPIN, INHIBIN A AND PAPP-A METHODS IN CLINICAL CHEMISTRY SYSTEMS. IN VITRO DIAGNOSTIC AGENT. PAIR

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)
CONTROL DE CALIDAD
Trade Name (English)
QUALITY CONTROL
Registration Information
Analysis ID
1884R2018 SSA
Registration Date
August 03, 2018
Manufacturer / Fabricante
Name (English)
INTEGRAL SOLUTION TO YOUR REGULATORY NEEDS, S.A. DE C.V.