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EQUIPO DE EIA DE ACTIVACIÓN DE COMPLEMENTO (CAE) - COFEPRIS Registration 604R2019 SSA

Access comprehensive regulatory information for EQUIPO DE EIA DE ACTIVACIÓN DE COMPLEMENTO (CAE) (PLUG-IN ACTIVATION EIA (CAE) EQUIPMENT) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 604R2019 SSA and manufactured by DIASORIN MÉXICO S.A. DE C.V.. The device was registered on March 26, 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
604R2019 SSA
EQUIPO DE EIA DE ACTIVACIÓN DE COMPLEMENTO (CAE)
COFEPRIS Analysis ID: 604R2019 SSA
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Product Use / Uso del Producto
Spanish

PARA LA DETERMINACIÓN CUALITATIVA DE LA ACTIVIDAD CLÁSICA TOTAL DEL COMPLEMENTO EN SUERO HUMANO POR INMUNO ENSAYO ENZIMÁTICO (EIA). AGENTE DE DIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSIVO DE LABORATORIOS CLÍNICOS O DE GABINETE.

English

FOR THE QUALITATIVE DETERMINATION OF THE TOTAL CLASSICAL COMPLEMENT ACTIVITY IN HUMAN SERUM BY ENZYME IMMUNOASSAY (EIA). DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE OF CLINICAL OR CABINET LABORATORIES ONLY.

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 DETERMINACIÓN DE LA ACTIVIDAD CLÁSICA TOTAL DEL COMPLEMENTO
Trade Name (English)
REAGENTS FOR DETERMINATION OF TOTAL CLASSICAL COMPLEMENT ACTIVITY
Registration Information
Analysis ID
604R2019 SSA
Registration Date
March 26, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MEXICO S.A. DE C.V.