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EUROLABWORKSTATION ELISA - INVIMA Registration 50769f53bbb78b3422038bb4f69bd627

Access comprehensive regulatory information for EUROLABWORKSTATION ELISA (EUROLABWORKSTATION ELISA) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 50769f53bbb78b3422038bb4f69bd627 and manufactured by BYO COLOMBIA S.A.S.. The device was registered on May 03, 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.

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INVIMA Official Data
IIa
50769f53bbb78b3422038bb4f69bd627
EUROLABWORKSTATION ELISA
INVIMA Analysis ID: 50769f53bbb78b3422038bb4f69bd627
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Product Use / Uso del Producto
Spanish

EL EUROLABWORKSTATION ELISA ES UN DISPOSITIVO DE IVD UTILIZADO PARA LA REALIZACIร“N COMPLETAMENTE AUTOMรTICA DE ANรLISIS IN VITRO ELISA CON LOS SIGUIENTES MATERIALES DE MUESTRAS HUMANAS: SUERO, PLASMA, LIQUIDO CEFALORRAQUIDEO Y EXTRACTO DE GOTAS DE SANGRE SECA. ABARCA LOS PROCESOS DE: DILUCIร“N DE MUESTRAS, TRANSFERENCIA DE MATERIAL DE MUESTRA PRIMARIO O DE DILUCIONES DE MUESTRAS Y REACTIVOS SECUNDARIOS A LAS MICROPLACAS ELISA, INCUBACIร“N A DIFERENTES TEMPERATURAS, PROCESOS DE LAVADO, MEDICIร“N DE LA DENSIDAD ร“PTICA Y EVALUACIร“N DE LOS RESULTADOS DE MEDICIร“N. _x000D_ _x000D_ _x000D_

English

THE EUROLABWORKSTATION ELISA IS AN IVD DEVICE USED FOR FULLY AUTOMATIC PERFORMANCE OF IN VITRO ELISA ANALYSIS WITH THE FOLLOWING HUMAN SAMPLE MATERIALS: SERUM, PLASMA, CEREBROSPINAL FLUID, AND DRIED BLOOD SPOT EXTRACT. IT COVERS THE PROCESSES OF: DILUTION OF SAMPLES, TRANSFER OF PRIMARY SAMPLE MATERIAL OR DILUTIONS OF SAMPLES AND SECONDARY REAGENTS TO ELISA MICROPLATES, INCUBATION AT DIFFERENT TEMPERATURES, WASHING PROCESSES, MEASUREMENT OF OPTICAL DENSITY AND EVALUATION OF MEASUREMENT RESULTS. _x000D_ _x000D_ _x000D_

Device Classification
Risk Class / Clase de Riesgo
IIa
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
50769f53bbb78b3422038bb4f69bd627
Expire Date
May 03, 2034
Authorized Company / Fabricante
Name (Spanish)
BYO COLOMBIA S.A.S.
Name (English)
BYO COLOMBIA S.A.S.