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ARGENE® SARS-COV-2 R-GENE® - INVIMA Registration ce2415ceda5c9944b4a714aa86137d2b

Access comprehensive regulatory information for ARGENE® SARS-COV-2 R-GENE® (ARGENE® SARS-COV-2 R-GENE®) in the Colombia medical device market through Pure Global AI's free database. This medical device is registered under INVIMA analysis ID ce2415ceda5c9944b4a714aa86137d2b and manufactured by BIOMERIEUX S.A.. The device was registered on April 06, 2030.

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
ce2415ceda5c9944b4a714aa86137d2b
ARGENE® SARS-COV-2 R-GENE®
INVIMA Analysis ID: ce2415ceda5c9944b4a714aa86137d2b
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Product Use / Uso del Producto
Spanish

EL KIT SARS-COV-2 R-GENE® ES UN KIT DE USO EXCLUSIVO PARA INVESTIGACIÓN (RUO) QUE CONTIENE TODOS LOS REACTIVOS NECESARIOS PARA DETECTAR EN MUESTRAS RESPIRATORIAS:_x000D_ • PCR1: ESPECÍFICAMENTE EL GENOMA DEL SARS-COV-2 Y EL GEN RDRP DEL SARS-COV-2._x000D_ • PCR2: GENÉRICAMENTE EL SARS, EL SARS-COV-2 Y / O GENOMAS SIMILARES AL SARS EN UNA REACCIÓN TRIPLE: GEN E DEL SARS, SARS-COV-2 Y / O SIMILAR AL SARS.

English

THE SARS-COV-2 R-GENE® KIT IS A RESEARCH KIT (RUO) CONTAINING ALL THE REAGENTS NEEDED TO DETECT IN RESPIRATORY SAMPLES:_x000D_ • PCR1: SPECIFICALLY THE SARS-COV-2 GENOME AND THE SARS-COV-2._x000D_ RDRP GENE • PCR2: GENERICALLY SARS, SARS-COV-2 AND/OR SARS-LIKE GENOMES IN A TRIPLE REACTION: SARS GENE E, SARS-COV-2 AND/OR SARS-LIKE.

Device Classification
Product Type (Spanish)
REACTIVOS IN VITRO
Product Type (English)
REACTIVOS IN VITRO
Registration Information
Analysis ID
ce2415ceda5c9944b4a714aa86137d2b
Expire Date
April 06, 2030
Authorized Company / Fabricante
Name (Spanish)
BIOMERIEUX S.A.
Name (English)
BIOMERIEUX S.A.