FOSFOMYCIN - INVIMA Registration cfd6aa1ba749189b97a8bc3ffc0faeae
Access comprehensive regulatory information for FOSFOMYCIN (FOSFOMYCIN) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID cfd6aa1ba749189b97a8bc3ffc0faeae and manufactured by BIOMERIEUX SA. The device was registered on February 28, 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.
ETEST®_x000D_ ES UNA TÉCNICA CUANTITATIVA MANUAL PARA LA DETERMINACIÓN DE LA SUSCEPTIBILIDAD ANTIMICROBIANA DE LAS BACTERIAS_x000D_ AEROBIAS GRAMPOSITIVAS Y GRAMNEGATIVAS NO EXIGENTES Y BACTERIAS EXIGENTES. EL SISTEMA COMPRENDE UN GRADIENTE DE_x000D_ ANTIBIÓTICO PREDEFINIDO QUE SE UTILIZA PARA DETERMINAR LA CONCENTRACIÓN MÍNIMA INHIBITORIA (CMI, EN µG/ML) DE DIFERENTES_x000D_ AGENTES ANTIMICROBIANOS FRENTE A MICROORGANISMOS SEMBRADOS EN MEDIO DE AGAR TRAS UNA NOCHE DE INCUBACIÓN. SE HA DEMOSTRADO QUE LA FOSFOMICINA ES ACTIVA FRENTE A LOS MICROORGANISMOS AEROBIOS SIGUIENTES, SEGÚN LAS ETIQUETAS DE_x000D_ LA EMA Y LAS DE FDA PARA ESTE AGENTE ANTIMICROBIANO._x000D_ ETEST®_x000D_ FO SE PUEDE EMPLEAR PARA DETERMINAR LA CMI DE LA FOSFOMICINA FRENTE A LOS SIGUIENTES MICROORGANISMOS:_x000D_ ACTIVA TANTO IN VITRO COMO EN INFECCIONES CLÍNICAS:_x000D_ ETIQUETA EMA:_x000D_ • CITROBACTER FREUNDII_x000D_ • CITROBACTER KOSERI_x000D_ • ESCHERICHIA COLI_x000D_ • KLEBSIELLA AEROGENES_x000D_ • KLEBSIELLA PNEUMONIAE_x000D_ • KLEBSIELLA OXYTOCA_x000D_ • SALMONELLA ENTERICA_x000D_ • SERRATIA MARCESCENS_x000D_ • STAPHYLOCCOCUS AUREUS_x000D_ • STAPHYLOCCOCUS EPIDERMIDIS_x000D_ ETIQUETA DE LA FDA:_x000D_ • ENTEROCOCCUS FAECALIS_x000D_ • ESCHERICHIA COLI
ETEST®_x000D_ IT IS A MANUAL QUANTITATIVE TECHNIQUE FOR THE DETERMINATION OF THE ANTIMICROBIAL SUSCEPTIBILITY OF BACTERIAS_x000D_ GRAM-POSITIVE AND GRAM-NEGATIVE NON-DEMANDING AEROBES AND DEMANDING BACTERIA. THE SYSTEM COMPRISES A GRADIENT DE_x000D_ A PREDEFINED ANTIBIOTIC USED TO DETERMINE THE MINIMUM INHIBITORY CONCENTRATION (MIC, IN μG/ML) OF DIFERENTES_x000D_ ANTIMICROBIAL AGENTS AGAINST MICROORGANISMS PLANTED IN AGAR MEDIUM AFTER ONE NIGHT OF INCUBATION. FOSFOMYCIN HAS BEEN SHOWN TO BE ACTIVE AGAINST THE FOLLOWING AEROBIC MICROORGANISMS ACCORDING TO LABELS DE_x000D_ THE EMA AND FDA FOR THIS AGENT ANTIMICROBIANO._x000D_ ETEST®_x000D_ FO CAN BE USED TO DETERMINE THE MIC OF FOSFOMYCIN AGAINST THE FOLLOWING ORGANISMS:_x000D_ ACTIVE BOTH IN VITRO AND IN CLINICAL INFECTIONS:_x000D_ EMA TAG:_x000D_ • CITROBACTER FREUNDII_x000D_ • CITROBACTER KOSERI_x000D_ • ESCHERICHIA COLI_x000D_ • KLEBSIELLA AEROGENES_x000D_ • KLEBSIELLA PNEUMONIAE_x000D_ • KLEBSIELLA OXYTOCA_x000D_ • SALMONELLA ENTERICA_x000D_ • SERRATIA MARCESCENS_x000D_ • STAPHYLOCCOCUS AUREUS_x000D_ • STAPHYLOCCOCUS EPIDERMIDIS_x000D_ FDA ETIQUETTE:_x000D_ • ENTEROCOCCUS FAECALIS_x000D_ •ESCHERICHIA COLI