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SIMPLEXA™ FLU A/B & RSV DIRECT - COFEPRIS Registration 250R2019 SSA

Access comprehensive regulatory information for SIMPLEXA™ FLU A/B & RSV DIRECT (SIMPLEXA™ FLU A/B & RSV DIRECT) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 250R2019 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on February 12, 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
250R2019 SSA
SIMPLEXA™ FLU A/B & RSV DIRECT
COFEPRIS Analysis ID: 250R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO SIMPLEXA™ FLU A/B & RSV DIRECT 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, EL ARN DEL VIRUS DE LA GRIPE B Y EL ARN DEL VIRUS DE LA GRIPE A, EL A

English

THE SIMPLEXA™ FLU A/B & RSV DIRECT ASSAY HAS BEEN DESIGNED FOR USE IN LIAISON® MDX EQUIPMENT FOR THE QUALITATIVE DETECTION AND IN VITRO DIFFERENTIATION OF INFLUENZA A VIRUS RNA, INFLUENZA B VIRUS RNA AND INFLUENZA A VIRUS RNA, A

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 PARA LA DETECCIÓN Y DIFERENCIACIÓN DE ARN VIRAL DE LA GRIPE A, GRIPE B Y EL VIRUS SINCITIAL R
Trade Name (English)
ASSAY FOR THE DETECTION AND DIFFERENTIATION OF VIRAL RNA OF INFLUENZA A, INFLUENZA B AND SYNCYTIAL R VIRUS
Registration Information
Analysis ID
250R2019 SSA
Registration Date
February 12, 2019
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.