STANDARD™ F SYPHILIS AB FIA - INVIMA Registration 23da39cc0c53efc64ddf937940e91ad5
Access comprehensive regulatory information for STANDARD™ F SYPHILIS AB FIA (STANDARD™ F SYPHILIS AB FIA) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 23da39cc0c53efc64ddf937940e91ad5 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.
STANDARD F SYPHILIS AB FIA ES UN INMUNOENSAYO FLUORESCENTE PARA LA DETECCIÓN CUALITATIVA DE _x000D_ ANTICUERPOS CONTRA EL AGENTE CAUSANTE DE LA SÍFILIS A PARTIR DE SUERO, PLASMA O SANGRE ENTERA DE _x000D_ ORIGEN HUMANO. LA PRUEBA ES PARA USO DIAGNÓSTICO IN VITRO Y ESTÁ CONCEBIDA COMO AYUDA PARA EL _x000D_ DIAGNÓSTICO PRECOZ DE LA SÍFILIS. ES SOLO PARA USO PROFESIONAL. LA PRUEBA SOLO PROPORCIONA UN RESULTADO _x000D_ DE DETECCIÓN INICIAL. DEBE UTILIZARSE UN MÉTODO ALTERNATIVO DE DIAGNÓSTICO ESPECÍFICO CON EL FIN DE _x000D_ OBTENER LA CONFIRMACIÓN DE LA INFECCIÓN.
STANDARD F SYPHILIS AB FIA IS A FLUORESCENT IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF _x000D_ ANTIBODIES TO THE CAUSATIVE AGENT OF SYPHILIS FROM SERUM, PLASMA, OR WHOLE BLOOD OF _x000D_ HUMAN ORIGIN. THE TEST IS FOR IN VITRO DIAGNOSTIC USE AND IS INTENDED AS AN AID TO _x000D_ EARLY DIAGNOSIS OF SYPHILIS. IT IS FOR PROFESSIONAL USE ONLY. THE TEST ONLY PROVIDES A _x000D_ RESULT OF INITIAL DETECTION. A SPECIFIC ALTERNATIVE DIAGNOSTIC METHOD SHOULD BE USED IN ORDER TO _x000D_ GET CONFIRMATION OF THE INFECTION.