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ROCHE CARDIAC POC NT-PROBNP - INVIMA Registration f8a9bac8a3cbefb39de48791e09e536f

Access comprehensive regulatory information for ROCHE CARDIAC POC NT-PROBNP (ROCHE CARDIAC POC NT-PROBNP) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID f8a9bac8a3cbefb39de48791e09e536f and manufactured by ROCHE DIAGNOSTICS GMBH. The device was registered on May 31, 2034.

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
f8a9bac8a3cbefb39de48791e09e536f
ROCHE CARDIAC POC NT-PROBNP
INVIMA Analysis ID: f8a9bac8a3cbefb39de48791e09e536f
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Product Use / Uso del Producto
Spanish

ROCHE CARDIAC POC NT-PROBNP ES UN TEST DE _x000D_ DIAGNÓSTICO IN VITRO PARA LA DETERMINACIÓN _x000D_ CUANTITATIVA DE NT-PROBNP EN SANGRE VENOSA _x000D_ TRATADA CON HEPARINA PARA USO CON EL INSTRUMENTO_x000D_ COBAS H 232. EL TEST ROCHE CARDIAC POC NT-PROBNP _x000D_ CONTRIBUYE AL DIAGNÓSTICO DE PACIENTES CON _x000D_ SOSPECHA DE INSUFICIENCIA CARDÍACA, LA _x000D_ MONITORIZACIÓN DE PACIENTES CON TRASTORNO _x000D_ FUNCIONAL VENTRICULAR IZQUIERDO COMPENSADO Y LA_x000D_ ESTRATIFICACIÓN DEL RIESGO EN PACIENTES CON _x000D_ SÍNDROMES CORONARIOS AGUDOS. CONTRIBUYE A _x000D_ EVALUAR EL RIESGO CARDIOVASCULAR EN LOS PACIENTES_x000D_ CON DIABETES MELLITUS DE TIPO 2. ADEMÁS, PUEDE _x000D_ AYUDAR EN LA IDENTIFICACIÓN DE PACIENTES CON _x000D_ DIABETES MELLITUS TIPO 2 CON RIESGO CARDIOVASCULAR _x000D_ DE DESARROLLAR ENFERMEDADES CARDIOVASCULARES, _x000D_ SIN ANTECEDENTES CONOCIDOS DE ENFERMEDAD _x000D_ CARDIOVASCULAR, PARA OPTIMIZAR EL TRATAMIENTO _x000D_ CARDIOPROTECTOR. EL TEST PUEDE USARSE PARA _x000D_ IDENTIFICAR A LOS INDIVIDUOS DE MAYOR EDAD CON_x000D_ ALTO RIESGO DE FIBRILACIÓN AURICULAR. EL TEST SE HA_x000D_ CONCEBIDO PARA PRUEBAS CERCA DEL PACIENTE. NO _x000D_ APTO PARA AUTODIAGNÓSTICO.

English

ROCHE CARDIAC POC NT-PROBNP IS A _x000D_ IN VITRO DIAGNOSTICS FOR _x000D_ DETERMINATION QUANTITATIVE NT-PROBNP IN VENOUS BLOOD _x000D_ TREATED WITH HEPARIN FOR USE WITH INSTRUMENTO_x000D_ COBAS H 232. THE ROCHE CARDIAC POC NT-PROBNP TEST _x000D_ CONTRIBUTES TO THE DIAGNOSIS OF PATIENTS WITH _x000D_ SUSPECTED HEART FAILURE, _x000D_ MONITORING OF PATIENTS WITH _x000D_ DISORDER COMPENSATED LEFT VENTRICULAR FUNCTION AND LA_x000D_ RISK STRATIFICATION IN PATIENTS WITH _x000D_ ACUTE CORONARY SYNDROMES. CONTRIBUTE TO _x000D_ ASSESS CARDIOVASCULAR RISK IN PACIENTES_x000D_ WITH TYPE 2 DIABETES MELLITUS. IN ADDITION, IT CAN _x000D_ ASSIST IN THE IDENTIFICATION OF PATIENTS WITH _x000D_ TYPE 2 DIABETES MELLITUS WITH CARDIOVASCULAR RISK _x000D_ OF DEVELOPING CARDIOVASCULAR DISEASE, _x000D_ NO KNOWN HISTORY OF _x000D_ DISEASE TO OPTIMIZE THE TREATMENT _x000D_ CARDIOPROTECTIVE. THE TEST CAN BE USED TO _x000D_ IDENTIFY OLDER INDIVIDUALS CON_x000D_ HIGH RISK OF ATRIAL FIBRILLATION. THE TEST IS HA_x000D_ DESIGNED FOR TESTING CLOSE TO THE PATIENT. DON'T _x000D_ SUITABLE FOR SELF-DIAGNOSIS.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
f8a9bac8a3cbefb39de48791e09e536f
Expire Date
May 31, 2034
Authorized Company / Fabricante
Name (English)
ROCHE DIAGNOSTICS GMBH