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EPLEX®RESPIRATORYPATHOGENPANEL RP - COFEPRIS Registration 1601R2020 SSA

Access comprehensive regulatory information for EPLEX®RESPIRATORYPATHOGENPANEL RP (EPLEX®RESPIRATORYPATHOGENPANEL RP) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1601R2020 SSA and manufactured by KABLA COMERCIAL, S.A. DEC.V.. The device was registered on December 01, 2020.

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
1601R2020 SSA
EPLEX®RESPIRATORYPATHOGENPANEL RP
COFEPRIS Analysis ID: 1601R2020 SSA
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Product Use / Uso del Producto
Spanish

ELPANELEPLEX®PARALAIDENTIFICACIÓNDEPATÓGENOS RESPIRATORIOS (RP) ES UNAPRUEBA DE DIAGNÓSTICO IN VITROCUALITATIVO DE ÁCIDOS NUCLEICOSMÚLTIPLEX QUE SE UTILIZA EN ELINSTRUMENTO EPLEX PARA LA DETECCIÓN EIDENTIFICACIÓN CUALITATIVA SIMULTÁNEA DEMÚLTIPLES ÁCIDOS NUCLEICOS VIRALES YBACTERIANOS RESPIRATORIOS EN HISOPOSNASOFARÍNGEOS (NPS) OBTENIDOS DEPERSONAS QUE PRESENTAN SIGNOS YSÍNTOMAS DE INFECCIÓN DEL TRACTORESPIRATORIO.

English

THE PANELEPLEX FOR THE IDENTIFICATION OF RESPIRATORY PATHOGENS (RP) IS AN IN VITROQUALITATIVE DIAGNOSTIC APPROVAL OF NUCLEIC ACIDS MULTIPLEX USED IN THE EPLEX®INSTRUMENT FOR THE SIMULTANEOUS DETECTION AND QUALITATIVE IDENTIFICATION OF MULTIPLE RESPIRATORY VIRAL AND BACTERIAL NUCLEIC ACIDS IN NASOPHARYNGEAL SWABS (NPS) OBTAINED FROM PERSONS PRESENTING WITH SIGNS AND SYMPTOMS OF RESPIRATORY TRACT INFECTION.

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)
PANEL PARA IDENTIFICACIONCUALITATIVADEACIDOSNUCLEICOSVIRALES Y BACTERIANOSRESPIRATORIOS EN MUE
Trade Name (English)
PANEL FOR IDENTIFICATIONCUALITATIVADENUCLEICOSVIRALS AND BACTERIANOSRESPIRATORY IN MUE
Registration Information
Analysis ID
1601R2020 SSA
Registration Date
December 01, 2020
Manufacturer / Fabricante
Name (English)
KABBALAH COMMERCIAL, S.A. DEC.V.