Pure Global

SIMPLEXA™ DENGUE - COFEPRIS Registration 1523R2019 SSA

Access comprehensive regulatory information for SIMPLEXA™ DENGUE (SIMPLEXA™ DENGUE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1523R2019 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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase II
1523R2019 SSA
SIMPLEXA™ DENGUE
COFEPRIS Analysis ID: 1523R2019 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

LA PRUEBA SIMPLEXATM DENGUE DE DIASORIN MOLECULAR ES UN ENSAYO DE REACCIÓN EN CADENA DE LA POLIMERASA EN TIEMPO REAL (RTPCR) QUE ESTÁ DESTINADO A SU USO EN EL EQUIPO LIAISON® MDX PARA LA DETECCIÓN IN VITRO Y TIPIFICACIÓN DE LOS SEROTIPOS 1, 2, 3 Y 4 DEL V

English

THE MOLECULAR DIASORIN DENGUE SIMPLEXATM TEST IS A REAL-TIME POLYMERASE CHAIN REACTION (RTPCR) ASSAY THAT IS INTENDED FOR USE IN LIAISON® MDX EQUIPMENT FOR IN VITRO DETECTION AND TYPING OF V SEROTYPES 1, 2, 3 AND 4

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)
PRUEBA DE RT-PCR PARA LA DETECCIÓN Y TIPIFICACIÓN DEL VIRUS DEL DENGUE DE LOS SEROTIPOS 1, 2, 3 Y 4.
Trade Name (English)
RT-PCR TEST FOR THE DETECTION AND TYPING OF DENGUE VIRUS OF SEROTYPES 1, 2, 3 AND 4.
Registration Information
Analysis ID
1523R2019 SSA
Registration Date
August 01, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MEXICO S.A. DE C.V.