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VIDAS KUBE CLINICAL - ANALIZADOR DE INMUNOENSAYO VIDAS KUBE CLINICAL - INVIMA Registration 47674738fffbe5e39f22509f90e1a297

Access comprehensive regulatory information for VIDAS KUBE CLINICAL - ANALIZADOR DE INMUNOENSAYO VIDAS KUBE CLINICAL (VIDAS KUBE CLINICAL - VIDAS KUBE CLINICAL 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 47674738fffbe5e39f22509f90e1a297 and manufactured by BIOMERIEUX SA. The device was registered on June 06, 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.

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INVIMA Official Data
IIa
47674738fffbe5e39f22509f90e1a297
VIDAS KUBE CLINICAL - ANALIZADOR DE INMUNOENSAYO VIDAS KUBE CLINICAL
INVIMA Analysis ID: 47674738fffbe5e39f22509f90e1a297
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Product Use / Uso del Producto
Spanish

EL SISTEMA VIDAS KUBE ES UN SISTEMA DE INMUNODIAGNÓSTICO COMPLETO, INDEPENDIENTE Y MODULAR DESTINADO A TÉCNICOS Y JEFES DE LABORATORIO FORMADOS Y CUALIFICADOS. EL SISTEMA VIDAS KUBE ESTÁ DESTINADO A UTILIZARSE CON LOS KITS DE ENSAYOS VIDAS PARA USO CLÍNICO._x000D_ _x000D_ EL INSTRUMENTO VIDAS KUBE ES UN SISTEMA DE INMUNODIAGNÓSTICO COMPACTO, MULTIPARAMÉTRICO Y AUTOMATIZADO. UTILIZANDO CARTUCHOS DE REACTIVOS Y RECEPTÁCULOS DE FASE SÓLIDA (CONOS SPR) ESPECIALMENTE RECUBIERTOS, EL INSTRUMENTO VIDAS KUBE CONTROLA Y ANALIZA LAS MUESTRAS SIN NINGUNA INTERVENCIÓN DEL USUARIO. EL SISTEMA DE DETECCIÓN UTILIZA LA TECNOLOGÍA DE ENSAYO DE FLUORESCENCIA LIGADO A ENZIMAS (ENZYME LINKED FLUORESCENT ASSAY O ELFA) PARA OBTENER LOS RESULTADOS DE CADA PRUEBA. DESPUÉS DE HABER DISPENSADO LAS MUESTRAS, EL VIDAS KUBE REALIZA AUTOMÁTICAMENTE LAS DIFERENTES ETAPAS DEL ANÁLISIS. EL SOFTWARE DEL VIDAS KUBE PROCESA LOS ENSAYOS SEGÚN LOS CÓDIGOS DE BARRAS DE LOS CARTUCHOS Y PUEDE ENVIAR LOS RESULTADOS A UN SISTEMA DE INFORMACIÓN DE LABORATORIO.

English

THE KUBE VIDAS SYSTEM IS A COMPLETE, INDEPENDENT AND MODULAR IMMUNODIAGNOSTIC SYSTEM FOR TRAINED AND QUALIFIED TECHNICIANS AND LABORATORY MANAGERS. THE KUBE VIDAS SYSTEM IS INTENDED FOR USE WITH VIDAS TEST KITS FOR USE CLÍNICO._x000D_ _x000D_ THE VIDAS KUBE INSTRUMENT IS A COMPACT, MULTI-PARAMETRIC AND AUTOMATED IMMUNODIAGNOSTIC SYSTEM. USING SPECIALLY COATED REAGENT CARTRIDGES AND SOLID-PHASE RECEPTACLES (SPR CONES), THE VIDAS KUBE INSTRUMENT MONITORS AND ANALYZES SAMPLES WITHOUT ANY USER INTERVENTION. THE DETECTION SYSTEM USES ENZYME LINKED FLUORESCENT ASSAY (ELFA) ASSAY TECHNOLOGY TO OBTAIN THE RESULTS OF EACH TEST. AFTER THE SAMPLES HAVE BEEN DISPENSED, THE KUBE LIVES AUTOMATICALLY PERFORMS THE DIFFERENT STAGES OF THE ANALYSIS. THE KUBE LIVES SOFTWARE PROCESSES THE ASSAYS ACCORDING TO THE BARCODES ON THE CARTRIDGES AND CAN SEND THE RESULTS TO A LABORATORY INFORMATION SYSTEM.

Device Classification
Risk Class / Clase de Riesgo
IIa
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
47674738fffbe5e39f22509f90e1a297
Expire Date
June 06, 2033
Authorized Company / Fabricante
Name (Spanish)
BIOMERIEUX SA
Name (English)
BIOMERIEUX SA