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BIOFIRE JOINT INFECTION (JI) PANEL - INVIMA Registration 2cfb1527651e2b901c3d1eebfcdf4a9c

Access comprehensive regulatory information for BIOFIRE JOINT INFECTION (JI) PANEL (BIOFIRE JOINT INFECTION (JI) PANEL) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID 2cfb1527651e2b901c3d1eebfcdf4a9c and manufactured by BIOMERIEUX SA. The device was registered on May 26, 2033.

This page provides complete registration details including product type (DIAGNOSTIC REAGENT), authorised information, and regulatory compliance data from the official Colombia INVIMA medical device database. Pure Global AI offers free access to Colombia's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate INVIMA regulations efficiently.

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INVIMA Official Data
II
2cfb1527651e2b901c3d1eebfcdf4a9c
BIOFIRE JOINT INFECTION (JI) PANEL
INVIMA Analysis ID: 2cfb1527651e2b901c3d1eebfcdf4a9c
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Product Use / Uso del Producto
Spanish

BIOFIRE® JOINT INFECTION (JI) PANEL ES UNA PRUEBA DE DIAGNÓSTICO IN VITRO MULTIPLEX DE ÁCIDO NUCLEICO PREVISTA PARA SU USO_x000D_ CON LOS SISTEMAS BIOFIRE® FILMARRAY® 2.0 Y BIOFIRE® FILMARRAY® TORCH PARA LA DETECCIÓN E IDENTIFICACIÓN CUALITATIVAS_x000D_ SIMULTÁNEAS DE VARIOS ÁCIDOS NUCLEICOS DE BACTERIAS Y LEVADURAS, Y GENES DE RESISTENCIA A LOS ANTIBIÓTICOS SELECCIONADOS_x000D_ DEL LÍQUIDO SINOVIAL OBTENIDO DE INDIVIDUOS CON SOSPECHA DE INFECCIÓN ARTICULAR.

English

BIOFIRE® JOINT INFECTION (JI) PANEL IS AN IN VITRO MULTIPLEX NUCLEIC ACID DIAGNOSTIC TEST INTENDED FOR YOUR USO_x000D_ WITH THE BIOFIRE FILMARRAY® 2.0 AND BIOFIRE®® FILMARRAY® TORCH SYSTEMS FOR CUALITATIVAS_x000D_ DETECTION AND IDENTIFICATION SIMULTANEOUS TESTS OF SEVERAL NUCLEIC ACIDS FROM BACTERIA AND YEAST, AND ANTIBIOTIC RESISTANCE GENES SELECCIONADOS_x000D_ SYNOVIAL FLUID OBTAINED FROM INDIVIDUALS WITH SUSPECTED JOINT INFECTION.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
2cfb1527651e2b901c3d1eebfcdf4a9c
Expire Date
May 26, 2033
Authorized Company / Fabricante
Name (Spanish)
BIOMERIEUX SA
Name (English)
BIOMERIEUX SA