SOFIA® STREP A+ FIA - INVIMA Registration 8f3200f321a881bc7fe22c2c339bfd7b
Access comprehensive regulatory information for SOFIA® STREP A+ FIA (SOFIA STREP A+ FIA®) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID 8f3200f321a881bc7fe22c2c339bfd7b and manufactured by ORTHO-CLINICAL DIAGNOSTICS COLOMBIA S.A.S. The device was registered on August 15, 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.
EL FIA SOFIA STREP A+ DETECTA LOS ANTÍGENOS DE _x000D_ ESTREPTOCOCOS DEL GRUPO A EN LOS EXUDADOS _x000D_ FARÍNGEOS DE PACIENTES CON SIGNOS Y SÍNTOMAS DE _x000D_ FARINGITIS, COMO EL DOLOR DE GARGANTA. TODOS LOS_x000D_ RESULTADOS NEGATIVOS DE LA PRUEBA DEBEN SER_x000D_ CONFIRMADOS MEDIANTE CULTIVO BACTERIANO O BIEN _x000D_ MEDIANTE UNA PRUEBA MOLECULAR AUTORIZADA POR LA _x000D_ FDA, YA QUE LOS RESULTADOS NEGATIVOS NO EXCLUYEN _x000D_ UNA INFECCIÓN POR ESTREPTOCOCOS DEL GRUPO A Y NO _x000D_ DEBE USARSE COMO LA ÚNICA BASE DE TRATAMIENTO. LA _x000D_ PRUEBA ESTÁ PREVISTA PARA USO PROFESIONAL Y EN EL _x000D_ LABORATORIO COMO UNA AYUDA EN EL DIAGNÓSTICO DE _x000D_ INFECCIÓN POR ESTREPTOCOCOS DEL GRUPO A. EL FIA _x000D_ SOFIA STREP A+ PUEDE USARSE CON SOFIA O SOFIA 2._x000D_
THE SOFIA STREP A+ AFI DETECTS THE ANTIGENS OF _x000D_ GROUP A STREPTOCOCCI IN THE EXUDATES _x000D_ PHARYNGEAL OF PATIENTS WITH SIGNS AND SYMPTOMS OF _x000D_ PHARYNGITIS, SUCH AS A SORE THROAT. ALL LOS_x000D_ NEGATIVE TEST RESULTS MUST SER_x000D_ CONFIRMED BY BACTERIAL CULTURE OR _x000D_ BY MEANS OF A MOLECULAR TEST AUTHORIZED BY THE _x000D_ FDA, AS NEGATIVE RESULTS DO NOT EXCLUDE _x000D_ A GROUP A STREP INFECTION AND NOT _x000D_ IT SHOULD BE USED AS THE SOLE BASIS OF TREATMENT. THE _x000D_ THE TEST IS INTENDED FOR PROFESSIONAL USE AND IN THE _x000D_ LABORATORY AS AN AID IN THE DIAGNOSIS OF _x000D_ GROUP A STREP INFECTION. THE AIF _x000D_ SOFIA STREP A+ CAN BE USED WITH SOFIA OR SOFIA 2._x000D_