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MODULARDX KIT INFA H9 - INVIMA Registration 1b10c0ae65a95ffe2e22dfb0dce87790

Access comprehensive regulatory information for MODULARDX KIT INFA H9 (MODULARDX KIT INFA H9) in the Colombia medical device market through Pure Global AI's free database. This I medical device is registered under INVIMA analysis ID 1b10c0ae65a95ffe2e22dfb0dce87790 and manufactured by TIB MOLBIOL SYNTHESELABOR GMBH. The device was registered on July 13, 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
I
1b10c0ae65a95ffe2e22dfb0dce87790
MODULARDX KIT INFA H9
INVIMA Analysis ID: 1b10c0ae65a95ffe2e22dfb0dce87790
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Product Use / Uso del Producto
Spanish

LOS REACTIVOS LIGHTMIX Y MODULARDX RUO AMPARADOS EN ES ESTE REGISTRO SANITARIO SON REACTIVOS PARA LA DETECCIÒN Y/O CUANTIFICACIÓN EN MUESTRAS BIOLOGICAS DE ORIGEN HUMANO, DE LOS ACIDOS NUCLÉICOS DNA/RNA DE MICROORGANISMOS PATÓGENOS, GENES O MUTACIONES GENETICAS DE LA CÉLULAS SOMÁTICAS DE LOS INDIVIDUOS PARA LA DETERMINACIÓN DE UNA CONDICIÓN PARTICULAR. SU PLATAFORMA TECNOLÓGICA ES POR TECNICAS DE BIOLOGIA MOLECULAR POR AMPLIFICACIÓN EN CADENA DE POLIMERASA PCR.

English

THE LIGHTMIX AND MODULARDX RUO REAGENTS COVERED IN THIS SANITARY REGISTRY ARE REAGENTS FOR THE DETECTION AND / OR QUANTIFICATION IN BIOLOGICAL SAMPLES OF HUMAN ORIGIN, OF THE NUCLEIC ACIDS DNA / RNA OF PATHOGENIC MICROORGANISMS, GENES OR GENETIC MUTATIONS OF THE SOMATIC CELLS OF INDIVIDUALS FOR THE DETERMINATION OF A PARTICULAR CONDITION. ITS TECHNOLOGICAL PLATFORM IS BY MOLECULAR BIOLOGY TECHNIQUES BY PCR POLYMERASE CHAIN AMPLIFICATION.

Device Classification
Risk Class / Clase de Riesgo
I
Product Type (Spanish)
REACTIVOS IN VITRO
Product Type (English)
REACTIVOS IN VITRO
Registration Information
Analysis ID
1b10c0ae65a95ffe2e22dfb0dce87790
Expire Date
July 13, 2032
Authorized Company / Fabricante
Name (English)
TIB MOLBIOL SYNTHESELABOR GMBH