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MONKEYPOX VIRUS - INVIMA Registration 8fa3acf5cfdeae78ce2e23fedfdcf6cb

Access comprehensive regulatory information for MONKEYPOX VIRUS (MONKEYPOX VIRUS) in the Colombia medical device market through Pure Global AI's free database. This medical device is registered under INVIMA analysis ID 8fa3acf5cfdeae78ce2e23fedfdcf6cb and manufactured by LABCARE DE COLOMBIA LTDA.. The device was registered on August 19, 2032.

This page provides complete registration details including product type (REACTIVOS IN VITRO), 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
8fa3acf5cfdeae78ce2e23fedfdcf6cb
MONKEYPOX VIRUS
INVIMA Analysis ID: 8fa3acf5cfdeae78ce2e23fedfdcf6cb
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Product Use / Uso del Producto
Spanish

VIASURE MONKEYPOX VIRUS REAL TIME PCR DETECTION_x000D_ KIT ES UNA PRUEBA DE PCR EN TIEMPO REAL DISEÑADA _x000D_ PARA LA IDENTIFICACIÓN CUALITATIVA DE DNA DEL VIRUS _x000D_ DE LA VIRUELA DEL MONO EN MUESTRAS CLÍNICAS DE _x000D_ PERSONAS SOSPECHOSAS DE INFECCIÓN POR EL VIRUS _x000D_ DE LA VIRUELA DEL MONO POR SU PROFESIONAL DE LA _x000D_ SALUD. EL USO PREVISTO DEL TEST ES CON FINES DE _x000D_ INVESTIGACIÓN, SIN NINGÚN OBJETIVO MÉDICO, NO SE_x000D_ CONSIDERAN DISPOSITIVOS PARA LA EVALUACIÓN DEL _x000D_ RENDIMIENTO. EL DNA ES EXTRAÍDO DE MUESTRAS _x000D_ CLÍNICAS, Y POSTERIORMENTE AMPLIFICADO MEDIANTE _x000D_ PCR A TIEMPO REAL. LA DETECCIÓN SE LLEVA A CABO _x000D_ UTILIZANDO OLIGONUCLEÓTIDOS ESPECÍFICOS Y SONDAS_x000D_ MARCADAS CON UNA MOLÉCULA FLUORESCENTE Y OTRA _x000D_ APANTALLADORA (QUENCHER) PARA DETECTAR VIRUS DE _x000D_ LA VIRUELA DEL MONO

English

VIASURE MONKEYPOX VIRUS REAL TIME PCR DETECTION_x000D_ KIT IS A REAL-TIME PCR TEST DESIGNED _x000D_ FOR QUALITATIVE DNA IDENTIFICATION OF THE _x000D_ VIRUS OF MONKEYPOX IN CLINICAL SAMPLES OF _x000D_ PEOPLE SUSPECTED OF INFECTION WITH THE _x000D_ VIRUS MONKEYPOX BY YOUR _x000D_ PROFESSIONAL BLESS YOU. THE INTENDED USE OF THE TEST IS FOR _x000D_ PURPOSES RESEARCH, WITHOUT ANY MEDICAL OBJECTIVE, DOES NOT SE_x000D_ CONSIDER DEVICES FOR THE EVALUATION OF _x000D_ YIELD. DNA IS EXTRACTED FROM SAMPLES _x000D_ CLINICS, AND SUBSEQUENTLY AMPLIFIED BY _x000D_ REAL-TIME PCR. DETECTION IS CARRIED OUT _x000D_ USING SPECIFIC OLIGONUCLEOTIDES AND SONDAS_x000D_ LABELED WITH ONE FLUORESCENT MOLECULE AND ANOTHER _x000D_ QUENCHER TO DETECT _x000D_ VIRUSES MONKEYPOX

Device Classification
Product Type (Spanish)
REACTIVOS IN VITRO
Product Type (English)
REACTIVOS IN VITRO
Registration Information
Analysis ID
8fa3acf5cfdeae78ce2e23fedfdcf6cb
Expire Date
August 19, 2032
Authorized Company / Fabricante
Name (English)
LABCARE DE COLOMBIA LTDA.