ONSITE HIV AG_AB 4TH GEN RAPID TEST - INVIMA Registration a50f23b97f3d0cc81febcb6c104c6711
Access comprehensive regulatory information for ONSITE HIV AG_AB 4TH GEN RAPID TEST (ONSITE HIV AG_AB 4TH GEN RAPID TEST) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID a50f23b97f3d0cc81febcb6c104c6711 and manufactured by BIOLORE LTDA..
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 ONSITE HIV AG/AB 4TH GEN. RAPID TEST ES UN _x000D_ INMUNOENSAYO DE FLUJO LATERAL PARA LA DETECCIÓN _x000D_ CUALITATIVA DE ANTICUERPOS (IGG, IGM, IGA) CONTRA EL _x000D_ VI H- 1( INCLUIDO EL O) Y VIH-2 Y EL ANTÍGENO P 2 4 DEL _x000D_ VIH - 1 EN SUERO, PLASMA O SANGRE TOTAL HUMANA. _x000D_ ESTÁ DESTINADO A SER UTILIZADO POR PROFESIONALES_x000D_ DE SALUD PARA AYUDAR EN EL DIAGNÓSTICO DE LA_x000D_ INFECCIÓN CON VIH. CUALQUIER USO O INTERPRETACIÓN _x000D_ DE ESTOS RESULTADOS PRELIMINARES DEBE TENER EN _x000D_ CUENTA OTRAS EVIDENCIAS CLÍNICAS Y LA OPINIÓN _x000D_ PROFESIONAL DEL PERSONAL DE LA SALUD. DEBE _x000D_ CONSIDERARSE EL USO DE MÉTODOS ALTERNATIVOS_x000D_ PARA CONFIRMAR LOS RESULTADOS OBTENIDOS POR ESTA_x000D_ PRUEBA.
THE ONSITE HIV AG/AB 4TH GEN. RAPID TEST IS A _x000D_ LATERAL FLOW IMMUNOASSAY FOR THE DETECTION _x000D_ QUALITATIVE ANTIBODY (IGG, IGM, IGA) AGAINST _x000D_ VI H-1 ( INCLUDING O) AND HIV-2 AND P2 4 ANTIGEN OF _x000D_ HIV-1 IN SERUM, PLASMA, OR WHOLE HUMAN BLOOD. _x000D_ IT IS INTENDED TO BE USED BY PROFESIONALES_x000D_ TO AID IN THE DIAGNOSIS OF LA_x000D_ HIV INFECTION. ANY USE OR INTERPRETATION _x000D_ OF THESE PRELIMINARY RESULTS YOU SHOULD TAKE INTO ACCOUNT _x000D_ TELL OTHER CLINICAL EVIDENCE AND THE OPINION _x000D_ HEALTH PERSONNEL PROFESSIONAL. MUST _x000D_ CONSIDER USING ALTERNATIVOS_x000D_ METHODS TO CONFIRM THE RESULTS OBTAINED BY ESTA_x000D_ TEST.