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TOTAL HUMAN IGE ELISA. - COFEPRIS Registration 1926R2019 SSA

Access comprehensive regulatory information for TOTAL HUMAN IGE ELISA. (TOTAL HUMAN IGE 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 1926R2019 SSA and manufactured by DIAGMEX, S.A. DE C.V.. The device was registered on September 27, 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
1926R2019 SSA
TOTAL HUMAN IGE ELISA.
COFEPRIS Analysis ID: 1926R2019 SSA
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Product Use / Uso del Producto
Spanish

INMUNOENSAYO ENZIMรTICO CUANTITATIVO DE INMUNOGLOBULINA E (IGE) QUE PROPORCIONA UN ENSAYO RรPIDO, SENSIBLE Y CONFIABLE PARA LA IGE Sร‰RICA TOTAL. PARA USARSE UNA SOLA VEZ. AGENTE DE DIAGNร“STICO IN VIRO. PARA USO EXCLUSIVO DE LABORATORIOS CLรNICOS O DE GABI

English

QUANTITATIVE IMMUNOGLOBULIN E (IGE) ENZYME IMMUNOASSAY PROVIDING A RAPID, SENSITIVE, AND RELIABLE ASSAY FOR TOTAL SERUM IGE. FOR ONE-TIME USE. IN VIRO DIAGNOSTIC AGENT. FOR USE BY CLINICAL LABORATORIES OR GABI ONLY

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
REACTIVOS PARA LA DETERMINACIร“N DE LA CONCENTRACIร“N DE INMUNOGLOBULINA E (IGE).
Trade Name (English)
REAGENTS FOR THE DETERMINATION OF IMMUNOGLOBULIN E (IGE) CONCENTRATION.
Registration Information
Analysis ID
1926R2019 SSA
Registration Date
September 27, 2019
Manufacturer / Fabricante
Name (Spanish)
DIAGMEX, S.A. DE C.V.
Name (English)
DIAGMEX, S.A. DE C.V.