HUBI FABP-TROPONIN I. - COFEPRIS Registration 1515R2021 SSA
Access comprehensive regulatory information for HUBI FABP-TROPONIN I. (HUBI FABP-TROPONIN I.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1515R2021 SSA and manufactured by KABLACOMERCIAL,S.A.DE C.V.. The device was registered on September 29, 2021.
This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
HUBI FABP-TROPONIN I ES UNA PRUEBARÁPIDAPARAPUNTOSDEATENCIÓNBASADAEN ENSAYO DE INMUNOCROMATOGRAFIAQUESE UTILIZAENELHUBI-QUANPROPARAMEDIR DE FORMA CUANTITATIVA LAPROTEÍNA DE UNIÓN DE ÁCIDOS GRASOSCARDIACOS (H-FABP) Y LA TROPONINA I(CTNI)ENMUESTRASDESANGREENTERAOPLASMAANTICOAGULADAEDTA. LAPRUEBAES UN MÉTODO DIAGNÓSTICO ÚTIL EN LOSPACIENTES CON INFARTO AGUDO DEMIOCARDIO. AGENTE DE DIAGNÓSTICO INVITRO. PARA USO EXCLUSIVO DELABORATORIOS CLÍNICOS O DE GABINETE.
HUBI FABP-TROPONIN I IS A RAPID POINT-OFCARE TEST BASED ON IMMUNOCHROMATOGRAPHY ASSAY THAT IS USED IN THE HUBI-QUAN TO QUANTITATIVELY MEASURE CARDIAC FATTY ACID BINDING PROTEIN (H-FABP) AND TROPONIN I(CTNI) IN WHOLE BLOOD SAMPLES OR ANTICOAGULATED PLASMA. THE TEST IS A USEFUL DIAGNOSTIC METHOD IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION. INVITRO DIAGNOSTIC AGENT. FOR EXCLUSIVE USE OF CLINICAL OR CABINET LABORATORIES.