ADVIA CENTAUR ANTI-HBE2 (AHBE2) - INVIMA Registration cb3fd35a3a758793cd95de184893f2e4
Access comprehensive regulatory information for ADVIA CENTAUR ANTI-HBE2 (AHBE2) (ADVIA CENTAUR ANTI-HBE2 (AHBE2)) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID cb3fd35a3a758793cd95de184893f2e4 and manufactured by SIEMENS HEALTHCARE 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.
EL ENSAYO ANTI-HBE2 (AHBE2) DE ADVIA CENTAUR® ES UN INMUNOENSAYO DE DIAGNÓSTICO IN VITRO PARA _x000D_ LA DETECCIÓN CUALITATIVA DE ANTICUERPOS CONTRA EL ANTÍGENO E DEL VIRUS DE LA HEPATITIS B (VHB) EN _x000D_ PACIENTES PEDIÁTRICOS HUMANOS (DE 2 A 21 AÑOS) Y EN SUERO ADULTO, PLASMA CON EDTA O PLASMA CON _x000D_ HEPARINA DE LITIO MEDIANTE LOS SISTEMAS ADVIA CENTAUR XP Y ADVIA CENTAUR XPT EN PACIENTES CON _x000D_ SIGNOS O SÍNTOMAS DE INFECCIÓN POR HEPATITIS B, O CON FACTORES DE RIESGO DE INFECCIÓN POR VHB, O _x000D_ CON INFECCIÓN POR VHB CONOCIDA. LOS RESULTADOS DEL ENSAYO, JUNTO CON OTRA INFORMACIÓN _x000D_ DIAGNÓSTICA, PUEDEN UTILIZARSE COMO AYUDA PARA DETERMINAR EL ESTADO CLÍNICO DEL VHB O PARA _x000D_ CONTROLAR LA ENFERMEDAD DEL VHB.
THE ADVIA CENTAUR® ANTI-HBE2 (AHBE2) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR _x000D_ QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B VIRUS E ANTIGEN (HBV) IN _x000D_ HUMAN PAEDIATRIC PATIENTS (2 TO 21 YEARS OF AGE) AND ADULT SERUM, PLASMA WITH EDTA OR PLASMA WITH _x000D_ LITHIUM HEPARIN USING THE ADVIA CENTAUR XP AND ADVIA CENTAUR XPT SYSTEMS IN PATIENTS WITH _x000D_ SIGNS OR SYMPTOMS OF HEPATITIS B INFECTION, OR WITH RISK FACTORS FOR HBV INFECTION, OR _x000D_ WITH KNOWN HBV INFECTION. THE RESULTS OF THE TRIAL, ALONG WITH OTHER INFORMATION _x000D_ DIAGNOSTIC, THEY CAN BE USED TO HELP DETERMINE THE CLINICAL STATUS OF HBV OR TO _x000D_ CONTROL HBV DISEASE.