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EBV IGM ELISA - COFEPRIS Registration 1501R2018 SSA

Access comprehensive regulatory information for EBV IGM ELISA (EBV IGM 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 1501R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on June 13, 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
1501R2018 SSA
EBV IGM ELISA
COFEPRIS Analysis ID: 1501R2018 SSA
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Product Use / Uso del Producto
Spanish

LA PRUEBA EBV IGM ELISA ESTÁ DESTINADA PARA LA DETECCIÓN DE ANTICUERPOS DE TIPO INMUNOGLOBULINA M (IGM) HACIA EL ANTÍGENO CÁPSIDE DEL VIRUS DE EPSTEIN-BARR (EBV) EN SUERO HUMANO. EL ANTÍGENO CÁPSIDE ES EL INMUNÓGENO PRINCIPAL QUE SIGUE UNA INFECCIÓN PRIMA

English

THE EBV IGM ELISA TEST IS INTENDED FOR THE DETECTION OF IMMUNOGLOBULIN M (IGM) ANTIBODIES TO EPSTEIN-BARR VIRUS (EBV) CAPSID ANTIGEN IN HUMAN SERUM. THE CAPSID ANTIGEN IS THE MAIN IMMUNOGEN THAT FOLLOWS A RAW INFECTION

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)
ANÁLISIS ELISA PARA LA DETECCIÓN DE ANTICUERPOS IGM HACIA EL VIRUS DE EPSTEIN-BARR
Trade Name (English)
ELISA ANALYSIS FOR THE DETECTION OF IGM ANTIBODIES TO EPSTEIN-BARR VIRUS
Registration Information
Analysis ID
1501R2018 SSA
Registration Date
June 13, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.