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HBA1C KIT - INVIMA Registration eacc70357dca268c85a7a8259dcbb56e

Access comprehensive regulatory information for HBA1C KIT (HBA1C KIT) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID eacc70357dca268c85a7a8259dcbb56e and manufactured by DISTRIBUIDORA Y COMERCIALIZADORA DIZAR LTDA.. The device was registered on January 29, 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
eacc70357dca268c85a7a8259dcbb56e
HBA1C KIT
INVIMA Analysis ID: eacc70357dca268c85a7a8259dcbb56e
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Product Use / Uso del Producto
Spanish

SE UTILIZA PARA LA DETECCION CUANTITATIVA IN VITRO DE LA CONCENTRACION DE HBA1C EN_x000D_ SANGRE ENTERA, SANGRE CAPILAR._x000D_ EL PROCESO DE FORMACION DE HBA1C ES EL GRUPO ALDEHIDO DE LA VALINA N-TERMINAL._x000D_ DE LA CADENA ฦ’ร€ DE LA HEMOGLOBINA Y EL GRUPO ALDEHIDO DE LA GLUCOSA SUFREN PRIMERO UNA_x000D_ REACCION DE ADICION RAPIDA PARA FORMAR UN PRODUCTO INTERMEDIO INESTABLE ALDIMINA (SCHIFF_x000D_ BASE), Y LUEGO SE SOMETEN A TRANSLOCACION DE AMADORI Y REORDENAMIENTO MOLECULAR. UN ESTABLO_x000D_ Y LENTAMENTE SE FORMA EL COMPUESTO IRREVERSIBLE DE CETOAMONIACO, HBA1C. EL_x000D_ LA CONCENTRACION DE HBA1C ES RELATIVAMENTE CONSTANTE, POR LO QUE LA HBA1C SE USA COMUNMENTE EN CLINICA._x000D_ PARA REPRESENTAR EL NIVEL TOTAL DE HEMOGLOBINA GLICOSILADA, QUE PUEDE REFLEJAR DIRECTAMENTE LA_x000D_ NIVEL DE AZUCAR EN LA SANGRE DEL CUERPO, Y ES UN MEJOR INDICADOR DE DETECCION PARA LA CLINICA_x000D_ MONITOREO DEL NIVEL DE CONTROL DE AZUCAR EN SANGRE DE PACIENTES DIABETICOS._x000D_ EN LA ACTUALIDAD, LOS METODOS DE DETECCION COMUNMENTE UTILIZADOS PARA HBA1C INCLUYEN EL ENZIMATICO._x000D_ METODO, INMUNOENSAYO DE INHIBICION TURBIDIMETRICA, INMUNOFLUORESCENCIA, FLUORESCENCIA_x000D_ INMUNOCROMATOGRAFIA, CROMATOGRAFIA DE AFINIDAD, ETC.

English

IT IS USED FOR IN VITRO QUANTITATIVE DETECTION OF HBA1C EN_x000D_ WHOLE BLOOD, CAPILAR._x000D_ BLOOD THE HBA1C FORMATION PROCESS IS THE ALDEHYDE GROUP OF VALINE N-TERMINAL._x000D_ OF THE HEMOGLOBIN CHAIN AND THE ALDEHYDE GROUP OF GLUCOSE FIRST SUFFER UNA_x000D_ RAPID ADDITION REACTION TO FORM AN UNSTABLE INTERMEDIATE ALDIMINE (SCHIFF_x000D_ BASE), AND THEN UNDERGO AMADORI TRANSLOCATION AND MOLECULAR REARRANGEMENT. A ESTABLO_x000D_ AND SLOWLY THE IRREVERSIBLE KETOAMMONIA COMPOUND, HBA1C, IS FORMED. EL_x000D_ THE CONCENTRATION OF HBA1C IS RELATIVELY CONSTANT, SO HBA1C IS COMMONLY USED IN CLINICA._x000D_ TO REPRESENT THE TOTAL LEVEL OF GLYCATED HEMOGLOBIN, WHICH CAN DIRECTLY REFLECT LA_x000D_ BLOOD SUGAR LEVEL IN THE BODY, AND IS A BETTER SCREENING INDICATOR FOR CLINICA_x000D_ MONITORING THE BLOOD SUGAR CONTROL LEVEL OF PATIENTS DIABETICOS._x000D_ AT PRESENT, COMMONLY USED DETECTION METHODS FOR HBA1C INCLUDE ENZIMATICO._x000D_ METHOD, TURBIDIMETRIC INHIBITION IMMUNOASSAY, IMMUNOFLUORESCENCE, FLUORESCENCIA_x000D_ IMMUNOCHROMATOGRAPHY, AFFINITY CHROMATOGRAPHY, ETC.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
eacc70357dca268c85a7a8259dcbb56e
Expire Date
January 29, 2034
Authorized Company / Fabricante
Name (English)
DISTRIBUTOR AND MARKETER DIZAR LTDA.