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VITEK - ANALIZADOR PARA MICROBIOLOGIA VITEK SERIE MS - INVIMA Registration 01ac777925cc9012f2a55f11d40cec5b

Access comprehensive regulatory information for VITEK - ANALIZADOR PARA MICROBIOLOGIA VITEK SERIE MS (VITEK - ANALYZER FOR VITEK MICROBIOLOGY MS SERIES) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 01ac777925cc9012f2a55f11d40cec5b and manufactured by BIOMERIEUX SA. The device was registered on July 01, 2032.

This page provides complete registration details including product type (SURGICAL DOCTOR), 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
IIa
01ac777925cc9012f2a55f11d40cec5b
VITEK - ANALIZADOR PARA MICROBIOLOGIA VITEK SERIE MS
INVIMA Analysis ID: 01ac777925cc9012f2a55f11d40cec5b
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Product Use / Uso del Producto
Spanish

ESPECTRÓMETRO DE MASAS DE TIEMPO DE VUELO CON IONIZACIÓN LÁSER ASISTIDA POR MATRIZ (MALDI-TOF-MS) PARA LA IDENTIFICACIÓN DE MICROORGANISMOS CULTIVADOS A PARTIR DE MUESTRAS HUMANAS._x000D_ EL SISTEMA VITEK® MS - VITEK® MS PRIME, ES UN DISPOSITIVO MÉDICO PARA DIAGNÓSTICO IN VITRO CUALITATIVO QUE SE UTILIZA JUNTO CON OTRAS PRUEBAS DE LABORATORIO COMO AYUDA EN EL DIAGNÓSTICO DE INFECCIONES BACTERIANAS, DE LEVADURAS Y HONGOS._x000D_ ESTÁ INDICADO PARA PROPORCIONAR RESULTADOS DE IDENTIFICACIÓN DE ORGANISMOS DE BACTERIAS (INCLUIDA MYCOBACTERIUM), HONGOS Y LEVADURAS, QUE PUEDEN UTILIZARSE JUNTO CON LOS RESULTADOS DE SENSIBILIDAD ANTIMICROBIANA PARA DETERMINAR O ADAPTAR EL TRATAMIENTO DEL PACIENTE Y SUPERVISAR PATRONES EPIDEMIOLÓGICOS._x000D_ EL SISTEMA VITEK® MS - VITEK® MS PRIME, NO ESTÁ DISEÑADO PARA LA TIPIFICACIÓN DE CEPAS O PARA LAS PRUEBAS DE SENSIBILIDAD ANTIMICROBIANA.

English

TIME-OF-FLIGHT MASS SPECTROMETER WITH MATRIX-ASSISTED LASER IONIZATION (MALDI-TOF-MS) FOR THE IDENTIFICATION OF CULTURED MICROORGANISMS FROM SAMPLES HUMANAS._x000D_ THE VITEK MS - VITEK®® MS PRIME SYSTEM IS A MEDICAL DEVICE FOR QUALITATIVE IN VITRO DIAGNOSIS THAT IS USED IN CONJUNCTION WITH OTHER LABORATORY TESTS AS AN AID IN THE DIAGNOSIS OF BACTERIAL, YEAST AND HONGOS._x000D_ INFECTIONS IT IS INDICATED TO PROVIDE ORGANISM IDENTIFICATION RESULTS OF BACTERIA (INCLUDING MYCOBACTERIUM), FUNGI AND YEASTS, WHICH CAN BE USED IN CONJUNCTION WITH ANTIMICROBIAL SENSITIVITY RESULTS TO DETERMINE OR TAILOR PATIENT TREATMENT AND MONITOR PATTERNS EPIDEMIOLÓGICOS._x000D_ THE VITEK MS - VITEK®® MS PRIME SYSTEM IS NOT DESIGNED FOR STRAIN TYPING OR ANTIMICROBIAL SENSITIVITY TESTING.

Device Classification
Risk Class / Clase de Riesgo
IIa
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
01ac777925cc9012f2a55f11d40cec5b
Expire Date
July 01, 2032
Authorized Company / Fabricante
Name (Spanish)
BIOMERIEUX SA
Name (English)
BIOMERIEUX SA