THUNDERBOLT EIA/EIA-CL ELISA ANALYZER - EQUIPO AUTOMATIZADO PARA PROCESAMIENTO EIA/CLIA - INVIMA Registration 8d4ca9014d2d4d1472020753a7ebd2b4
Access comprehensive regulatory information for THUNDERBOLT EIA/EIA-CL ELISA ANALYZER - EQUIPO AUTOMATIZADO PARA PROCESAMIENTO EIA/CLIA (THUNDERBOLT EIA/EIA-CL ELISA ANALYZER - AUTOMATED EQUIPMENT FOR EIA/CLIA PROCESSING) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 8d4ca9014d2d4d1472020753a7ebd2b4 and manufactured by BIOSCIENCES SAS. The device was registered on June 23, 2033.
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.
EL SISTEMA ESTÁ DISEÑADO PARA AUTOMATIZAR EL PROCESAMIENTO DE PRUEBAS DE INMUNOENSAYO ENZIMÁTICO (EIA) REF 00300 E INMUNOENSAYO ENZIMÁTICO (EIA) / INMUNOENSAYO QUIMIOLUMINISCENTE (CLIA) REF 00300 CL EN INSTRUMENTOS EIA/CLIA DE GOLD STANDARD DIAGNOSTICS (GSD). EL SISTEMA SÓLO DEBE SER UTILIZADO POR PERSONAL DEBIDAMENTE FORMADO._x000D_ EL USO PREVISTO DEL SISTEMA ES COMO ANALIZADOR QUÍMICO FOTOMÉTRICO DISCRETO DESTINADO A DUPLICAR LOS PROCEDIMIENTOS ANALÍTICOS MANUALES MEDIANTE LA REALIZACIÓN AUTOMÁTICA DE DIVERSOS PASOS, COMO EL PIPETEO, EL CALENTAMIENTO Y LA MEDICIÓN DE LA INTENSIDAD DEL COLOR. EL SISTEMA TAMBIÉN ESTÁ DISEÑADO PARA FUNCIONAR COMO UN "ACCESORIO" QUE SE UTILIZA CON OTRO DISPOSITIVO (ES DECIR, KIT DE PRUEBA DE ENSAYO) PARA PERMITIR QUE EL DISPOSITIVO SE UTILICE DE ACUERDO CON SU PROPÓSITO PREVISTO._x000D_
THE SYSTEM IS DESIGNED TO AUTOMATE THE PROCESSING OF ENZYME IMMUNOASSAY (EIA) REF 00300 AND ENZYME IMMUNOASSAY (EIA)/CHEMILUMINESCENT IMMUNOASSAY (CLIA) REF 00300 CL TESTS ON GOLD STANDARD DIAGNOSTICS (GSD) EIA/CLIA INSTRUMENTS. THE SYSTEM SHOULD ONLY BE USED BY PERSONNEL PROPERLY FORMADO._x000D_ THE INTENDED USE OF THE SYSTEM IS AS A DISCRETE PHOTOMETRIC CHEMICAL ANALYZER INTENDED TO DUPLICATE MANUAL ANALYTICAL PROCEDURES BY AUTOMATICALLY PERFORMING VARIOUS STEPS, SUCH AS PIPETTING, HEATING, AND COLOR INTENSITY MEASUREMENT. THE SYSTEM IS ALSO DESIGNED TO FUNCTION AS AN "ACCESSORY" THAT IS USED WITH ANOTHER DEVICE (I.E., TEST TEST KIT) TO ALLOW THE DEVICE TO BE USED IN ACCORDANCE WITH ITS PURPOSE PREVISTO._x000D_