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SIMPLEXA™ EBV - COFEPRIS Registration 1524R2019 SSA

Access comprehensive regulatory information for SIMPLEXA™ EBV (SIMPLEXA™ EBV) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1524R2019 SSA and manufactured by DIASORIN MÉXICO S.A. DE C.V.. The device was registered on August 01, 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 II
1524R2019 SSA
SIMPLEXA™ EBV
COFEPRIS Analysis ID: 1524R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO SIMPLEXATM EBV DE DIASORIN MOLECULAR ESTÁ DISEÑADO PARA LA CUANTIFICACIÓN IN VITRO DE LOS ÁCIDOS NUCLÉICOS DEL VIRUS DE EPSTEIN BARR EN MUESTRAS DE SANGRE COMPLETA UTILIZANDO EL LIAISON® MDX Y SIMPLEXA EBV QUANTITATION STANDARDS (PATRÓN DE CUANT

English

THE MOLECULAR DIASORIN SIMPLEXATM EBV ASSAY IS DESIGNED FOR IN VITRO QUANTIFICATION OF EPSTEIN BARR VIRUS NUCLEIC ACIDS IN WHOLE BLOOD SAMPLES USING THE MDX LIAISON® AND SIMPLEXA EBV QUANTITATION STANDARDS.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO DE PCR EN TIEMPO REAL PARA LA CUANTIFICACIÓN DEL VIRUS DE EPSTEIN-BARR (VEB)
Trade Name (English)
REAL-TIME PCR ASSAY FOR QUANTIFICATION OF EPSTEIN-BARR VIRUS (EVB)
Registration Information
Analysis ID
1524R2019 SSA
Registration Date
August 01, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MEXICO S.A. DE C.V.