EVIDENCE MULTISTAT - ANALIZADOR DE INMUNOENSAYO - INVIMA Registration 7a32dd316cfc036969d2f59545fea5a9
Access comprehensive regulatory information for EVIDENCE MULTISTAT - ANALIZADOR DE INMUNOENSAYO (EVIDENCE MULTISTAT - IMMUNOASSAY ANALYZER) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 7a32dd316cfc036969d2f59545fea5a9 and manufactured by BIOLORE LTDA. The device was registered on January 22, 2034.
This page provides complete registration details including product type (SURGICAL DOCTOR), 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.
EVIDENCE MULTISTAT ES UN SISTEMA DE MESA PARA ENSAYOS DE BIOCHIPS RANDOX. ESTÁ DESTINADO A IN VITRO CUALITATIVO, DETERMINACIÓN DE DIVERSOS MARCADORES DIAGNÓSTICOS, DROGAS DE ABUSO Y RESIDUOS DE DROGAS._x000D_ _x000D_ PRÁCTICAMENTE TODOS LOS PROCESOS DE INMUNOENSAYO SE REALIZAN AUTOMÁTICAMENTE EN UN CARTUCHO DE BIOCHIP SELLA DO Y AUTÓNOMO QUE CONTIENE LOS BIOCHIPS, LOS REACTIVOS, EL TAMPÓN DE LAVADO Y OTROS FLUIDOS NECESARIOS PARA REALIZAR LA PRUEBA._x000D_ _x000D_ LOS RESULTADOS DEL ENSAYO ESTÁN DETERMINADOS POR LA GENERACIÓN DE LUZ A PARTIR DE REACCIONES QUIMIOLUMINISCENTES QUE TIENEN LUGAR EN REGIONES DE PRUEBA DISCRETAS (DTR) (SITIOS DE REACCIÓN) EN LA SUPERFICIE DEL BIOCHIP. LA SALIDA DE LUZ ES DETECTADA POR UNA CÁMARA DE DISPOSITIVO DE CARGA ACOPLADA (CCD) EN EL SISTEMA EVIDENCE MULTISTAT QUE, JUNTO CON EL SOFTWARE DEL ANALIZADOR, SE UTILIZA PARA CUANTIFICAR LA SALIDA DE LUZ Y PRODUCIR RESULTADOS SIGNIFICATIVOS.
EVIDENCE MULTISTAT IS A BENCHTOP SYSTEM FOR RANDOX BIOCHIP TESTING. IT IS INTENDED FOR IN VITRO QUALITATIVE DETERMINATION OF VARIOUS DIAGNOSTIC MARKERS, DRUGS OF ABUSE AND RESIDUES OF DROGAS._x000D_ _x000D_ VIRTUALLY ALL IMMUNOASSAY PROCESSES ARE PERFORMED AUTOMATICALLY IN A SELF-CONTAINED, SEALED BIOCHIP CARTRIDGE THAT CONTAINS THE BIOCHIPS, REAGENTS, WASH BUFFER, AND OTHER FLUIDS NEEDED TO PERFORM THE PRUEBA._x000D_ _x000D_ THE ASSAY RESULTS ARE DETERMINED BY THE GENERATION OF LIGHT FROM CHEMILUMINESCENT REACTIONS THAT TAKE PLACE IN DISCRETE TEST REGIONS (DTR) (REACTION SITES) ON THE SURFACE OF THE BIOCHIP. LIGHT OUTPUT IS DETECTED BY A LOAD-COUPLED DEVICE (CCD) CAMERA IN THE EVIDENCE MULTISTAT SYSTEM WHICH, TOGETHER WITH THE ANALYZER SOFTWARE, IS USED TO QUANTIFY LIGHT OUTPUT AND PRODUCE MEANINGFUL RESULTS.