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DRY FLUORESCENCE IMMUNOASSAY ANALYZER/ ANALIZADOR DE INMUNOENSAYO DE FLUORESCENCIA EN SECO - INVIMA Registration e3006df124860e1067f98f966c2dbd12

Access comprehensive regulatory information for DRY FLUORESCENCE IMMUNOASSAY ANALYZER/ ANALIZADOR DE INMUNOENSAYO DE FLUORESCENCIA EN SECO (DRY FLUORESCENCE 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 e3006df124860e1067f98f966c2dbd12 and manufactured by BIOSCIENCES SAS. The device was registered on October 05, 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
e3006df124860e1067f98f966c2dbd12
DRY FLUORESCENCE IMMUNOASSAY ANALYZER/ ANALIZADOR DE INMUNOENSAYO DE FLUORESCENCIA EN SECO
INVIMA Analysis ID: e3006df124860e1067f98f966c2dbd12
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Product Use / Uso del Producto
Spanish

EL PRODUCTO ES UN SISTEMA DE PRUEBA DE TIRA DE INMUNOENSAYO DE FLUORESCENCIA DE TIPO SECO BASADO EN EL PRINCIPIO DE DETECCIÓN FOTOELÉCTRICA QUE DEBE SOPORTAR EL USO DE REACTIVO BASADO EN EL PRINCIPIO DE INMUNOCROMATOGRAFÍA DE FLUORESCENCIA._x000D_ ADMITE EL USO DE REACTIVOS SECOS ESPECÍFICOS BASADOS EN LA INMUNOCROMATOGRAFÍA DE FLUORESCENCIA Y SE UTILIZA PARA EL ENSAYO DE INMUNOFLUORESCENCIA DE MUESTRAS DEL CUERPO HUMANO. SE UTILIZA PARA EL DIAGNÓSTICO Y LA PRUEBA IN VITRO ÚNICAMENTE POR PARTE DEL PERSONAL DE LABORATORIO DE INSTITUCIONES MÉDICAS. PUEDE APLICARSE A LABORATORIOS CENTRALES, LABORATORIOS DE URGENCIAS Y DEPARTAMENTOS CLÍNICOS DE INSTITUCIONES MÉDICAS, ASÍ COMO A OTROS CENTROS DE SERVICIOS MÉDICOS (COMO CENTROS DE SERVICIOS MÉDICOS COMUNITARIOS) Y A EXÁMENES FÍSICOS._x000D_ TAMBIÉN ES APLICABLE A LOS LABORATORIOS DE INVESTIGACIÓN CIENTÍFICA.

English

THE PRODUCT IS A DRY-TYPE FLUORESCENCE IMMUNOASSAY STRIP TEST SYSTEM BASED ON THE PHOTOELECTRIC DETECTION PRINCIPLE THAT MUST WITHSTAND THE USE OF REAGENT BASED ON THE PRINCIPLE OF FLUORESCENCIA._x000D_ IMMUNOCHROMATOGRAPHY IT SUPPORTS THE USE OF SPECIFIC DRY REAGENTS BASED ON FLUORESCENCE IMMUNOCHROMATOGRAPHY AND IS USED FOR IMMUNOFLUORESCENCE ASSAY OF HUMAN BODY SAMPLES. IT IS USED FOR DIAGNOSIS AND IN VITRO TESTING ONLY BY LABORATORY PERSONNEL OF MEDICAL INSTITUTIONS. IT CAN BE APPLIED TO CENTRAL LABORATORIES, EMERGENCY LABORATORIES, AND CLINICAL DEPARTMENTS OF MEDICAL INSTITUTIONS, AS WELL AS TO OTHER MEDICAL SERVICE FACILITIES (SUCH AS COMMUNITY HEALTH SERVICE CENTERS) AND TO FÍSICOS._x000D_ IT IS ALSO APPLICABLE TO SCIENTIFIC RESEARCH LABORATORIES.

Device Classification
Risk Class / Clase de Riesgo
IIa
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
e3006df124860e1067f98f966c2dbd12
Expire Date
October 05, 2033
Authorized Company / Fabricante
Name (Spanish)
BIOSCIENCES SAS
Name (English)
BIOSCIENCES SAS