STANDARD™ F TB-FERON FIA (IFN-GAMMA) - INVIMA Registration cef1848c511f25ac26adf37b1210f33d
Access comprehensive regulatory information for STANDARD™ F TB-FERON FIA (IFN-GAMMA) (STANDARD™ F TB-FERON FIA (IFN-GAMMA)) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID cef1848c511f25ac26adf37b1210f33d and manufactured by QUIMIOLAB S.A.S.
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.
_x000D_ EL PRODUCTO STANDARD F TB-FERON FIA (IFN-GAMMA) ES UNA PRUEBA DE DIAGNÓSTICO IN VITRO QUE UTILIZA _x000D_ PROTEÍNAS RECOMBINANTES ESPECÍFICAS PARA TB (ESAT-6, CFP-10 Y TB 7.7) PARA ESTIMULAR CÉLULAS EN SANGRE _x000D_ ENTERA HEPARINIZADA. LA DETECCIÓN DE INTERFERÓN GAMMA (IFN-Y) POR INMUNOENSAYO DE FLUORESCENCIA (FIA) _x000D_ SE UTILIZA PARA IDENTIFICAR RESPUESTAS IN VITRO PARA AQUELLOS ANTÍGENOS TB RECOMBINANTES ASOCIADOS CON UNA _x000D_ INFECCIÓN DE TUBERCULOSIS MICOBACTERIANA. ESTA PRUEBA ESTÁ DISEÑADA PARA USARSE EN CONJUNTO CON EVALUACIÓN _x000D_ DE RIESGO, RADIOGRAFÍA Y OTRAS EVALUACIONES MÉDICAS Y DE DIAGNÓSTICO.
_x000D_ THE STANDARD F TB-FERON FIA (IFN-GAMMA) PRODUCT IS AN IN VITRO DIAGNOSTIC TEST THAT USES _x000D_ TB-SPECIFIC RECOMBINANT PROTEINS (ESAT-6, CFP-10, AND TB 7.7) TO STIMULATE CELLS IN BLOOD _x000D_ WHOLE HEPARINIZED. DETECTION OF INTERFERON GAMMA (IFN-Y) BY FLUORESCENCE IMMUNOASSAY (FIA) _x000D_ IT IS USED TO IDENTIFY IN VITRO RESPONSES FOR THOSE RECOMBINANT TB ANTIGENS ASSOCIATED WITH A _x000D_ MYCOBACTERIAL TUBERCULOSIS INFECTION. THIS TEST IS DESIGNED TO BE USED IN CONJUNCTION WITH _x000D_ ASSESSMENT RISK TESTS, X-RAYS, AND OTHER MEDICAL AND DIAGNOSTIC EVALUATIONS.