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QUIDEL TRIAGE® CARDIO2 PANEL - INVIMA Registration 45229f74414086470dcac0dbac9c1f88

Access comprehensive regulatory information for QUIDEL TRIAGE® CARDIO2 PANEL (QUIDEL TRIAGE® CARDIO2 PANEL) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID 45229f74414086470dcac0dbac9c1f88 and manufactured by ORTHO-CLINICAL DIAGNOSTICS COLOMBIA S.A.S. The device was registered on April 02, 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
45229f74414086470dcac0dbac9c1f88
QUIDEL TRIAGE® CARDIO2 PANEL
INVIMA Analysis ID: 45229f74414086470dcac0dbac9c1f88
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Product Use / Uso del Producto
Spanish

QUIDEL TRIAGE CARDIO3 PANEL ES UN FLUOROINMUNOANÁLISIS QUE SE UTILIZA EN COMVINACIÓN CON LOS MEDIDORES QUIDEL TRIAGE METER PARA LA DETERMINACIÓN CUANTITATIVA RÁPIDA DE LA CREATINA-CINASA MB, LA TROPONINA I Y EL PÉPTIDO NATRIURÉTICO TIPO B EN MUESTRAS DE PLASMA Y SANGRE ANTICOAGULADAS CON ÁCIDO EDÉTICO (EDTA). QUIDEL TRIAGE CARDIO3 PANEL ESTÁ PREVISTO PARA FACILITAR EL DIAGNÓSTICO DE INFARTO DE MICOCARDIO (LESIÓN), PERMITIR EL DIAGNÓSTICO Y LA EVALUACIÓN DE LA GRAVEDAD DE UNA INSUFICIENCIA CARDÍACA CONGESTIVA (TAMBIÉN LLAMADA "INSUFICIENCIA CARDÍACA") Y AYUDAR A LA ESTRATIFICACIÓN DE RIESGOS EN PACIENTES CON INSUFICIEWNCIA CARDÍACA Y LA ESTRATIFICACIÓN DE RIESGOS EN PACIENTES CON SÍNDROME CORONARIO AGUDO.

English

QUIDEL TRIAGE CARDIO3 PANEL IS A FLUOROIMMUNOASSAY USED IN COMBINATION WITH QUIDEL TRIAGE METER METERS FOR THE RAPID QUANTITATIVE DETERMINATION OF CREATINE KINASE MB, TROPONIN I AND B-TYPE NATRIURETIC PEPTIDE IN PLASMA AND BLOOD SAMPLES ANTICOAGULATED WITH EDETIC ACID (EDTA). QUIDEL TRIAGE CARDIO3 PANEL IS INTENDED TO FACILITATE THE DIAGNOSIS OF MYCOCARDIAL INFARCTION (INJURY), ENABLE THE DIAGNOSIS AND ASSESSMENT OF THE SEVERITY OF CONGESTIVE HEART FAILURE (ALSO CALLED "HEART FAILURE"), AND AID RISK STRATIFICATION IN PATIENTS WITH HEART FAILURE AND RISK STRATIFICATION IN PATIENTS WITH ACUTE CORONARY SYNDROME.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
45229f74414086470dcac0dbac9c1f88
Expire Date
April 02, 2034
Authorized Company / Fabricante
Name (English)
ORTHO-CLINICAL DIAGNOSTICS COLOMBIA S.A.S