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STANDARD™ F INFLUENZA A/B FIA - INVIMA Registration 2c5abe340b9d6b90d0a9ff3dfddfcaf0

Access comprehensive regulatory information for STANDARD™ F INFLUENZA A/B FIA (STANDARD™ F INFLUENZA A/B SON) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 2c5abe340b9d6b90d0a9ff3dfddfcaf0 and manufactured by QUIMIOLAB 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
2c5abe340b9d6b90d0a9ff3dfddfcaf0
STANDARD™ F INFLUENZA A/B FIA
INVIMA Analysis ID: 2c5abe340b9d6b90d0a9ff3dfddfcaf0
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Product Use / Uso del Producto
Spanish

STANDARD F INFLUENZA A/B FIA ES UN INMUNOENSAYO FLUORESCENTE PARA DETECTAR LA INFECCIÓN POR _x000D_ INFLUENZA EN MUESTRAS HUMANAS DE HISOPOS, LAVADOS O ASPIRADOS NASOFARÍNGEOS IDENTIFICANDO _x000D_ LA EXISTENCIA DEL VIRUS DE INFLUENZA TIPO A Y B. STANDARD F INFLUENZA A/B FIA DEBE USARSE CON LOS _x000D_ ANALIZADORES STANDARD F FABRICADOS POR SD BIOSENSOR. ESTE ESTÁ DESTINADO PARA USO PROFESIONAL, _x000D_ SOLO COMO UNA PRUEBA DE VALORACIÓN INICIAL.

English

STANDARD F INFLUENZA A/B FIA IS A FLUORESCENT IMMUNOASSAY FOR DETECTING _x000D_ INFECTION INFLUENZA IN HUMAN SWABS, WASHES, OR NASOPHARYNGEAL ASPIRATES IDENTIFYING _x000D_ THE EXISTENCE OF INFLUENZA A AND B VIRUSES. STANDARD F INFLUENZA A/B FIA SHOULD BE USED WITH _x000D_ STANDARD F ANALYZERS MANUFACTURED BY SD BIOSENSOR. THIS IS INTENDED FOR PROFESSIONAL USE, _x000D_ ONLY AS AN INITIAL PROOF OF ASSESSMENT.

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
2c5abe340b9d6b90d0a9ff3dfddfcaf0
Authorized Company / Fabricante
Name (Spanish)
QUIMIOLAB S.A.S
Name (English)
QUIMIOLAB S.A.S