EPLEX® BLOOD CULTUREIDENTIFICATION GRAM POSITIVE(BCID-GP) PANEL - COFEPRIS Registration 849R2021 SSA
Access comprehensive regulatory information for EPLEX® BLOOD CULTUREIDENTIFICATION GRAM POSITIVE(BCID-GP) PANEL (EPLEX® BLOOD CULTUREIDENTIFICATION GRAM POSITIVE(BCID-GP) 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 849R2021 SSA and manufactured by KABLA COMERCIAL, S.A. DE C.V.. The device was registered on May 14, 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.
ELPANELEPLEX®PARALAIDENTIFICACIÓNDEGRAMPOSITIVASENCULTIVOSDESANGRE(BDIC-GN)ESUNAPRUEBADEDIAGNÓSTICOINVITROCUALITATIVODEÁCIDOSNUCLEICOSMÚLTIPLEXDESTINADAPARALADETECCIÓNEIDENTIFICACIÓNCUALITATIVASIMULTÁNEADE MÚLTIPLES ORGANISMOS BACTERIANOSGRAM-POSITIVOS POTENCIALMENTEPATÓGENOS Y DETERMINANTES SELECTOSASOCIADOS CON LA RESISTENCIAANTIMICROBIANAENCULTIVOSSANGUÍNEOSPOSITIVOS.ADEMÁS,ELPANELEPLEXBCID-GP ES CAPAZ DE DETECTAR VARIASBACTERIAS GRAMNEGATIVO
THE PANELEPLEX®FOR GRAM-POSITIVE IDENTIFICATION IN BLOOD CULTURES (BDIC-GN) IS A MULTIPLEX-NUCLEIC ACID DIAGNOSTIC TEST INTENDED FOR SIMULTANEOUS DETECTION AND QUALITATIVE IDENTIFICATION OF MULTIPLE POTENTIALLY PATHOGENIC BACTERIAL-POSITIVE ORGANISMS AND SELECTED DETERMINANTS ASSOCIATED WITH ANTIMICROBIAL RESISTANCE IN POSITIVE BLOOD CULTURES. IN ADDITION, PANELEPLEXBCID-GP IS ABLE TO DETECT SEVERAL GRAM-NEGATIVE BACTERIA