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COLOSCREEN IFOBT - INVIMA Registration f3c86d74bf08b5226bde94667d11ffdf

Access comprehensive regulatory information for COLOSCREEN IFOBT (COLOSCREEN IFOBT) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID f3c86d74bf08b5226bde94667d11ffdf and manufactured by LABTRONICS S.A.S. The device was registered on January 31, 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.

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INVIMA Official Data
II
f3c86d74bf08b5226bde94667d11ffdf
COLOSCREEN IFOBT
INVIMA Analysis ID: f3c86d74bf08b5226bde94667d11ffdf
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Product Use / Uso del Producto
Spanish

HELENA COLOSCREEN PRUEBA INMUNOQUÍMICA DE SANGRE OCULTA EN LA MATERIA FECAL_x000D_ (IFOBT) ES UN DISPOSITIVO INMUNQUÍMICO PREVISTO PARA LA DETECCIÓN CUALITATIVA_x000D_ DE SANGRE OCULTA EN LA MATERIA FECAL EN LABORATORIOS O CONSULTAS MÉDICAS. ES ÚTIL_x000D_ PARA DETECTAR SANGRADO GASTROINTESTINAL (GI) QUE SE DA EN VARIAS ENFERMEDADES_x000D_ GASTROINTESTINALES, COMO: DIVERTICULITIS, COLITIS, PÓLIPOS Y CÁNCER COLORRECTAL. SE_x000D_ RECOMIENDA EL USO DE ESTA PRUEBA PARA: 1) RECONOCIMIENTOS MÉDICOS RUTINARIOS_x000D_ O CUANDO SE INGRESA POR PRIMERA VEZ A UN PACIENTE EN EL HOSPITAL, 2) SUPERVISIÓN_x000D_ EN HOSPITALES PARA PACIENTES CON SANGRADO GASTROINTESTINAL, Y 3) DETECCIÓN DEL_x000D_ CÁNCER COLORRECTAL O SANGRADO GASTROINTESTINAL.

English

HELENA COLOSCREEN IMMUNOCHEMICAL TEST OF OCCULT BLOOD IN MATTER FECAL_x000D_ (IFOBT) IT IS AN IMMUNOCHEMICAL DEVICE INTENDED FOR THE DETECTION CUALITATIVA_x000D_ OF FECAL OCCULT BLOOD IN LABORATORIES OR MEDICAL CONSULTATIONS. IT IS ÚTIL_x000D_ TO DETECT GASTROINTESTINAL (GI) BLEEDING THAT OCCURS IN SEVERAL ENFERMEDADES_x000D_ GASTROINTESTINAL, SUCH AS: DIVERTICULITIS, COLITIS, POLYPS AND COLORECTAL CANCER. SE_x000D_ IT RECOMMENDS THE USE OF THIS TEST FOR: 1) MEDICAL EXAMINATIONS RUTINARIOS_x000D_ OR WHEN A PATIENT IS FIRST ADMITTED TO THE HOSPITAL, 2) SUPERVISIÓN_x000D_ IN HOSPITALS FOR PATIENTS WITH GASTROINTESTINAL BLEEDING, AND 3) SCREENING DEL_x000D_ COLORECTAL CANCER OR GASTROINTESTINAL BLEEDING.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
f3c86d74bf08b5226bde94667d11ffdf
Expire Date
January 31, 2033
Authorized Company / Fabricante
Name (Spanish)
LABTRONICS S.A.S
Name (English)
LABTRONICS S.A.S