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SIMPLEXA™ CMV - COFEPRIS Registration 1352R2019 SSA

Access comprehensive regulatory information for SIMPLEXA™ CMV (SIMPLEXA™ CMV) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1352R2019 SSA and manufactured by DIASORIN MÉXICO S.A. DE C.V.. The device was registered on July 16, 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
1352R2019 SSA
SIMPLEXA™ CMV
COFEPRIS Analysis ID: 1352R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO SIMPLEXA™ CMV DE DIASORIN MOLECULAR ESTÁ DISEÑADO PARA LA CUANTIFICACIÓN IN VITRO DE LOS ÁCIDOS NUCLEICOS DEL CITOMEGALOVIRUS (CMV) EN MUESTRAS DE SANGRE COMPLETA Y PLASMA UTILIZANDO EL LIAISON® MDX. ESTE ENSAYO ESTÁ DISEÑADO PARA SER UTILIZADO

English

THE MOLECULAR DIASORIN SIMPLEXA™ CMV ASSAY IS DESIGNED FOR IN VITRO QUANTIFICATION OF CYTOMEGALOVIRUS (CMV) NUCLEIC ACIDS IN WHOLE BLOOD AND PLASMA SAMPLES USING MDX LIAISON®. THIS ASSAY IS DESIGNED TO BE USED

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 PARA LA CUANTIFICACIÓN DEL CITOMEGALOVIRUS (CMV).
Trade Name (English)
PCR ASSAY FOR QUANTIFICATION OF CYTOMEGALOVIRUS (CMV).
Registration Information
Analysis ID
1352R2019 SSA
Registration Date
July 16, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MEXICO S.A. DE C.V.