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FINECARETM IFOB RAPID QUANTITATIVE TEST - INVIMA Registration ed82eff9762784267a369bf68c4fecd8

Access comprehensive regulatory information for FINECARETM IFOB RAPID QUANTITATIVE TEST (FINECARETM IFOB RAPID QUANTITATIVE TEST ) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID ed82eff9762784267a369bf68c4fecd8 and manufactured by LUMIRA S.A.S. The device was registered on April 26, 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
ed82eff9762784267a369bf68c4fecd8
FINECARETM IFOB RAPID QUANTITATIVE TEST
INVIMA Analysis ID: ed82eff9762784267a369bf68c4fecd8
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Product Use / Uso del Producto
Spanish

LA PRUEBA CUANTITATIVA RÁPIDA IFOB ES UN _x000D_ INMUNOENSAYO DE FLUORESCENCIA QUE SE UTILIZA_x000D_ JUNTO CON LOS MEDIDORES FINECARE™ FIA (N.º DE _x000D_ MODELO: FS-113/FS-114/FS-205) PARA LA DETERMINACIÓN _x000D_ CUANTITATIVA DE SANGRE OCULTA EN LAS HECES (IFOB). _x000D_ ES ADECUADO PARA LA DETERMINACIÓN CUANTITATIVA DE_x000D_ HEMOGLOBINA (HB) EN HECES HUMANAS. CLÍNICAMENTE, _x000D_ SE UTILIZA PRINCIPALMENTE COMO AYUDA PARA LOS _x000D_ TRASTORNOS HEMORRÁGICOS GASTROINTESTINALES. _x000D_ SÓLO PARA USO DIAGNÓSTICO IN VITRO. SOLO PARA USO _x000D_ PROFESIONAL.

English

THE IFOB RAPID QUANTITATIVE TEST IS A _x000D_ FLUORESCENCE IMMUNOASSAY THAT IS UTILIZA_x000D_ TOGETHER WITH FINECARE™ FIA METERS (NO. _x000D_ MODEL: FS-113/FS-114/FS-205) FOR _x000D_ DETERMINATION QUANTITATIVE FECAL OCCULT BLOOD (IFOB). _x000D_ IT IS SUITABLE FOR THE QUANTITATIVE DETERMINATION DE_x000D_ HEMOGLOBIN (HB) IN HUMAN FECES. CLINICALLY, _x000D_ IT IS MAINLY USED AS AN AID FOR _x000D_ GASTROINTESTINAL BLEEDING DISORDERS. _x000D_ FOR IN VITRO DIAGNOSTIC USE ONLY. FOR _x000D_ USE ONLY PROFESSIONAL.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
ed82eff9762784267a369bf68c4fecd8
Expire Date
April 26, 2033
Authorized Company / Fabricante
Name (Spanish)
LUMIRA S.A.S
Name (English)
LUMIRA S.A.S