Pure Global

SIMPLEXA™ INFLUENZA A H1N1 (2009) - COFEPRIS Registration 294R2019 SSA

Access comprehensive regulatory information for SIMPLEXA™ INFLUENZA A H1N1 (2009) (SIMPLEXA™ INFLUENZA A H1N1 (2009)) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 294R2019 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on February 14, 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
294R2019 SSA
SIMPLEXA™ INFLUENZA A H1N1 (2009)
COFEPRIS Analysis ID: 294R2019 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 SIMPLEXA™ INFLUENZA A H1N1 (2009) SE HA DISEÑADO PARA SU USO EN EL EQUIPO LIAISON® MDX, PARA LA DETECCIÓN CUALITATIVA Y LA DIFERENCIACIÓN IN VITRO DEL ARN DEL VIRUS DE LA GRIPE A Y EL ARN DEL VIRUS DE LA GRIPE H1N1 2009 EN FROTIS NASOFARÍNGEOS,

English

THE SIMPLEXA influenza A H1N1 (2009) TEST IS DESIGNED FOR USE IN LIAISON® MDX EQUIPMENT FOR QUALITATIVE DETECTION AND IN VITRO DIFFERENTIATION OF INFLUENZA A VIRUS RNA AND 2009 H1N1 INFLUENZA VIRUS RNA™ IN NASOPHARYNGEAL SMEARS,

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 MOLECULAR PARA DETERMINACIÓN DEL ARN VIRAL DEL VIRUS A Y H1N1 2009
Trade Name (English)
MOLECULAR ASSAY FOR DETERMINATION OF VIRAL RNA OF VIRUS A AND H1N1 2009
Registration Information
Analysis ID
294R2019 SSA
Registration Date
February 14, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.