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TOTAL IMMUNOGLOBULIN E (IGE) - INVIMA Registration 2fa7e017e76e5a82c7d18187a749b6c9

Access comprehensive regulatory information for TOTAL IMMUNOGLOBULIN E (IGE) (TOTAL IMMUNOGLOBULIN E (IGE)) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID 2fa7e017e76e5a82c7d18187a749b6c9 and manufactured by BECKMAN COULTER COLOMBIA S.A.S.. The device was registered on September 05, 2032.

This page provides complete registration details including product type (DIAGNOSTIC REAGENT), 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
II
2fa7e017e76e5a82c7d18187a749b6c9
TOTAL IMMUNOGLOBULIN E (IGE)
INVIMA Analysis ID: 2fa7e017e76e5a82c7d18187a749b6c9
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Product Use / Uso del Producto
Spanish

EL ENSAYO IGE ESTÁ DISEÑADO PARA USARSE EN LA DETERMINACIÓN CUANTITATIVA DE LA CONCENTRACIÓN DE INMUNOGLOBULINA E (IGE) TOTAL EN SUERO Y PLASMA HUMANOS (HEPARINA DE LITIO, HEPARINA DE SODIO, K2 EDTA, K3 EDTA) EN ANALIZADORES DE QUÍMICA CLÍNICA AU/DXC AU BECKMAN COULTER. LA DETERMINACIÓN AYUDA EN EL DIAGNÓSTICO DE TRASTORNOS ALÉRGICOS MEDIADOS POR IGE JUNTO CON OTROS HALLAZGOS CLÍNICOS. ÚNICAMENTE PARA USO DIAGNÓSTICO IN VITRO.

English

THE IGE ASSAY IS DESIGNED FOR USE IN THE QUANTITATIVE DETERMINATION OF TOTAL IMMUNOGLOBULIN E (IGE) CONCENTRATION IN HUMAN SERUM AND PLASMA (LITHIUM HEPARIN, SODIUM HEPARIN, K2 EDTA, K3 EDTA) IN AU BECKMAN COULTER AU/DXC CLINICAL CHEMISTRY ANALYZERS. THE DETERMINATION AIDS IN THE DIAGNOSIS OF IGE-MEDIATED ALLERGIC DISORDERS ALONG WITH OTHER CLINICAL FINDINGS. FOR IN VITRO DIAGNOSTIC USE ONLY.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
2fa7e017e76e5a82c7d18187a749b6c9
Expire Date
September 05, 2032
Authorized Company / Fabricante
Name (English)
BECKMAN COULTER COLOMBIA S.A.S.