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EPLEX BLOOD CULTUREIDENTIFICATION FUNGALPATHOGEN (BCID-FP) PANEL - COFEPRIS Registration 790R2020 SSA

Access comprehensive regulatory information for EPLEX BLOOD CULTUREIDENTIFICATION FUNGALPATHOGEN (BCID-FP) PANEL (EPLEX BLOOD CULTUREIDENTIFICATION FUNGALPATHOGEN (BCID-FP) PANEL) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 790R2020 SSA and manufactured by KABLA COMERCIAL, S.A. DEC.V.. The device was registered on June 30, 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
790R2020 SSA
EPLEX BLOOD CULTUREIDENTIFICATION FUNGALPATHOGEN (BCID-FP) PANEL
COFEPRIS Analysis ID: 790R2020 SSA
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Product Use / Uso del Producto
Spanish

PRUEBA DE DIAGNÓSTICO IN VITROCUALITATIVAMÚLTIPLEXDEÁCIDOSNUCLEICOSDISEÑADA PARA LA DETECCIÓN EIDENTIFICACIÓN SIMULTÁNEA DE MÚLTIPLESORGANISMOS FÚNGICOS POTENCIALMENTEPATÓGENOS EN HEMOCULTIVOS POSITIVOS.EPLEX BCID-FP PANEL SE LLEVA A CABODIRECTAMENTE EN MUESTRAS DEHEMOCULTIVO IDENTIFICADAS COMOPOSITIVASPORUNSISTEMADEHEMOCULTIVODEMONITOREOCONTINUOYQUECONTENGANORGANISMOS FÚNGICOS. LOS SIGUIENTESORGANISMOS FÚNGICOS SON IDENTIFICADOSEMPLEANDO EPLEX BCID-FP PANEL: CANDID

English

IN VITRO QUALITATIVE DIAGNOSTIC TESTMULTIPLEXDENUCLEIC ACIDSDESIGNED FOR THE SIMULTANEOUS DETECTION AND IDENTIFICATION OF MULTIPLEPOTENTIALLY PATHOGENIC FUNGAL ORGANISMS IN POSITIVE BLOOD CULTURES. EPLEX BCID-FP PANEL IS CARRIED OUT DIRECTLY ON BLOOD CULTURE SAMPLES IDENTIFIED AS POSITIVE BY A CONTINUOUS MONITORING BLOOD CULTURE SYSTEM AND CONTAINING FUNGAL ORGANISMS. THE FOLLOWING FUNGAL ORGANISMS ARE IDENTIFIED USING EPLEX BCID-FP PANEL: CANDID

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 DE ÁCIDOS NUCLEICOSPARA IDENTIFICACIÓN DEPATOGENOS FUNGICOS ENHEMOCULTIVO
Trade Name (English)
NUCLEIC ACID ASSAY FOR IDENTIFICATION OF FUNGAL PATHOGENS IN BLOOD CULTURE
Registration Information
Analysis ID
790R2020 SSA
Registration Date
June 30, 2020
Manufacturer / Fabricante
Name (English)
KABBALAH COMMERCIAL, S.A. DEC.V.