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DENGUE REAL-TM GENOTYPE - INVIMA Registration 36a8f607237cc1a3e31c8f0aca6a9993

Access comprehensive regulatory information for DENGUE REAL-TM GENOTYPE (DENGUE REAL-TM GENOTYPE) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 36a8f607237cc1a3e31c8f0aca6a9993 and manufactured by AM ASESORIA Y MANTENIMIENTO LTDA.

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
36a8f607237cc1a3e31c8f0aca6a9993
DENGUE REAL-TM GENOTYPE
INVIMA Analysis ID: 36a8f607237cc1a3e31c8f0aca6a9993
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Product Use / Uso del Producto
Spanish

EL KIT DE PCR DENGUE REAL-TM GENOTYPE ES UNA PRUEBA DE AMPLIFICACIÓN DE ÁCIDO NUCLEICO IN VITRO PARA LA DETECCIÓN Y DIFERENCIACIÓN DEL ARN DEL VIRUS DEL DENGUE TIPO 1-4 EN MATERIALES CLÍNICOS (PLASMA SANGUÍNEO, SUERO SANGUÍNEO) Y EN MATERIALES DE AUTOPSIA HUMANA (CEREBRO, HÍGADO, TEJIDOS DEL BAZO), EN MATERIALES ANIMALES (CEREBRO, TEJIDOS DEL BAZO), EN MOSQUITOS MEDIANTE EL USO DE DETECCIÓN DE FLUORESCENCIA-HIBRIDACIÓN EN TIEMPO REAL DE PRODUCTOS AMPLIFICADOS. LOS RESULTADOS DEL ANÁLISIS DE PCR SE TIENEN EN CUENTA EN DIAGNÓSTICOS COMPLEJOS DE ENFERMEDADES

English

THE DENGUE REAL-TM GENOTYPE PCR KIT IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE DETECTION AND DIFFERENTIATION OF DENGUE VIRUS TYPE 1-4 RNA IN CLINICAL MATERIALS (BLOOD PLASMA, BLOOD SERUM) AND IN HUMAN AUTOPSY MATERIALS (BRAIN, LIVER, SPLEEN TISSUES), IN ANIMAL MATERIALS (BRAIN, SPLEEN TISSUES), IN MOSQUITOES BY USING REAL-TIME FLUORESCENCE-HYBRIDIZATION DETECTION OF AMPLIFIED PRODUCTS. PCR TEST RESULTS ARE TAKEN INTO ACCOUNT IN COMPLEX DISEASE DIAGNOSES

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
36a8f607237cc1a3e31c8f0aca6a9993
Authorized Company / Fabricante
Name (English)
AM ASESORIA Y MANTENIMIENTO LTDA