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MEXLAB BIO-INFLUENZA A+B - COFEPRIS Registration 1549R2021 SSA

Access comprehensive regulatory information for MEXLAB BIO-INFLUENZA A+B (MEXLAB BIO-INFLUENZA A+B) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1549R2021 SSA and manufactured by QUIMIBIOL, S.A. DE C.V.. The device was registered on April 10, 2021.

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 I
1549R2021 SSA
MEXLAB BIO-INFLUENZA A+B
COFEPRIS Analysis ID: 1549R2021 SSA
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Product Use / Uso del Producto
Spanish

LA PRUEBA RÁPIDA DE INFLUENZA A+B ENCASETE ES UN INMUNOENSAYO DE FLUJOLATERAL PARA LA DETECCIÓN CUALITATIVADELOSANTÍGENOSDEINFLUENZAAYBENMUESTRAS DE HISOPO NASOFARÍNGEO,HISOPODEGARGANTAO ASPIRADONASAL.ELOBJETIVODEESTAPRUEBAESAYUDARENEL DIAGNÓSTICO DIFERENCIAL RÁPIDO DELASINFECCIONESVIRALESDEINFLUENZAAYB. AGENTE DE DIAGNÓSTICO PARA USO INVITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLÍNICOS O DE GABINETE.

English

THE INFLUENZA A+B ENCASETE RAPID TEST IS A LATERAL FLOW IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF INFLUENZA ANTIGENSAND NASOPHARYNGEAL SWAB, THROAT SWAB OR NASAL ASPIRATION. THE AIM OF THIS TEST IS TO ASSIST IN THE RAPID DIFFERENTIAL DIAGNOSIS OF INFLUENZA AY VIRAL INFECTIONS. DIAGNOSTIC AGENT FOR INVITRO USE. FOR EXCLUSIVE USE IN CLINICAL OR CABINET LABORATORIES.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
KIT DE DIAGNÓSTICO IN VITRO PARAANTÍGENOSDELVIRUSDELAINFLUENZAAY B MEDIANTE PRUEBA RÁPIDA IN
Trade Name (English)
IN VITRO DIAGNOSTIC KIT FOR INFLUENZA VIRUS ANTIGENSAND B BY RAPID TEST IN
Registration Information
Analysis ID
1549R2021 SSA
Registration Date
April 10, 2021
Manufacturer / Fabricante
Name (English)
QUIMIBIOL, S.A. DE C.V.