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SYPHILIS ELISA IGG+IGM - INVIMA Registration 5b39634911ee41dae6cba366d37f0047

Access comprehensive regulatory information for SYPHILIS ELISA IGG+IGM (SYPHILIS ELISA IGG+IGM) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 5b39634911ee41dae6cba366d37f0047 and manufactured by ANNAR DIAGNOSTICA IMPORT S.A.S..

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
III
5b39634911ee41dae6cba366d37f0047
SYPHILIS ELISA IGG+IGM
INVIMA Analysis ID: 5b39634911ee41dae6cba366d37f0047
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Product Use / Uso del Producto
Spanish

PRUEBA INMUNOENZIMÁTICA INDIRECTA PARA DETERMINAR ANTICUERPOS IGG+IGM FRENTE A _x000D_ TREPONEMA PALLIDUM EN SUERO/PLASMA HUMANO. _x000D_ ESTE PRODUCTO ES UN ANÁLISIS CUALITATIVO Y MANUAL O AUTOMATIZADO, DESTINADO PARA _x000D_ SER USADO COMO AYUDA AL DIAGNÓSTICO.

English

INDIRECT ENZYME-LINKED IMMUNOSORBENT TEST TO DETERMINE IGG+IGM ANTIBODIES AGAINST _x000D_ TREPONEMA PALLIDUM IN HUMAN SERUM/PLASMA. _x000D_ THIS PRODUCT IS A QUALITATIVE AND MANUAL OR AUTOMATED ANALYSIS, INTENDED FOR _x000D_ BE USED AS A DIAGNOSTIC AID.

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
5b39634911ee41dae6cba366d37f0047
Authorized Company / Fabricante
Name (English)
ANNAR DIAGNOSTICA IMPORT S.A.S.