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I.MUNE TBNK (I.MUNE BY EPIMUNE) - INVIMA Registration 8a43070f1524b6aa5f313ac75c9993ab

Access comprehensive regulatory information for I.MUNE TBNK (I.MUNE BY EPIMUNE) (I.MUNE TBNK (I.MUNE BY EPIMUNE)) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID 8a43070f1524b6aa5f313ac75c9993ab and manufactured by SANITAS S.A.S. The device was registered on December 06, 2033.

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
II
8a43070f1524b6aa5f313ac75c9993ab
I.MUNE TBNK (I.MUNE BY EPIMUNE)
INVIMA Analysis ID: 8a43070f1524b6aa5f313ac75c9993ab
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Product Use / Uso del Producto
Spanish

I.MUNE TBNK ES UNA PRUEBA CUANTITATIVA IN VITRO PARA_x000D_ DETERMINAR LOS PORCENTAJES Y RECUENTOS _x000D_ ABSOLUTOS DE SUBCONJUNTOS DE LINFOCITOS HUMANOS_x000D_ EN SANGRE ENTERA VENOSA LรQUIDA Y PARA DETERMINAR_x000D_ LOS PORCENTAJES DE SUBCONJUNTOS DE LINFOCITOS _x000D_ HUMANOS EN MUESTRAS DE SANGRE ENTERA CAPILAR _x000D_ SECADA SOBRE PAPEL DE FILTRO (TARJETA CON GOTAS DE_x000D_ SANGRE SECA O DBS). LA PRUEBA UTILIZA UNA REACCIร“N _x000D_ EN CADENA DE LA POLIMERASA EN TIEMPO REAL CON _x000D_ SONDAS DE HIDRร“LISIS FLUORESCENTES PARA LA _x000D_ DETECCIร“N DE REGIONES DIANA GENร“MICAS _x000D_ DESMETILADAS ESPECรFICAS DEL TIPO DE Cร‰LULAS_x000D_ INMUNES ASOCIADAS CON LOS SIGUIENTES TIPOS DE _x000D_ Cร‰LULAS INMUNES:- LINFOCITOS T (CD3+) - LINFOCITOS B _x000D_ (CD19+) (BLC) - LINFOCITOS ASESINOS NATURALES _x000D_ (CD16+CD56DIM) (NATURAL KILLER CELLS; NKC) - LINFOCITOS_x000D_ T COLABORADORES (CD3+CD4+)_x000D_ โ€ข LINFOCITOS T CITOTร“XICOS (CD3+CD8+).

English

I.MUNE TBNK IS A QUANTITATIVE IN VITRO PARA_x000D_ TEST DETERMINE PERCENTAGES AND COUNTS _x000D_ ABSOLUTES OF LYMPHOCYTE SUBSETS HUMANOS_x000D_ IN LIQUID VENOUS WHOLE BLOOD AND FOR DETERMINAR_x000D_ PERCENTAGES OF LYMPHOCYTE SUBSETS _x000D_ HUMANS IN CAPILLARY WHOLE BLOOD SAMPLES _x000D_ DRIED ON FILTER PAPER (CARD WITH DE_x000D_ DROPS DRIED BLOOD OR DBS). THE TEST USES A REACTION _x000D_ REAL-TIME POLYMERASE CHAIN WITH _x000D_ FLUORESCENT HYDROLYSIS PROBES FOR _x000D_ DETECTION OF GENOMIC TARGET REGIONS _x000D_ SPECIFIC DEMETHYLATES OF THE TYPE OF Cร‰LULAS_x000D_ IMMUNE SYMPTOMS ASSOCIATED WITH THE FOLLOWING TYPES OF _x000D_ IMMUNE CELLS:- T LYMPHOCYTES (CD3+) - B LYMPHOCYTES _x000D_ (CD19+) (BLC) - NATURAL KILLER LYMPHOCYTES _x000D_ (CD16+CD56DIM) (NATURAL KILLER CELLS; NKC) - LINFOCITOS_x000D_ T COLLABORATORS (CD3+CD4+)_x000D_ โ€ข CYTOTOXIC T LYMPHOCYTES (CD3+CD8+).

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
8a43070f1524b6aa5f313ac75c9993ab
Expire Date
December 06, 2033
Authorized Company / Fabricante
Name (Spanish)
SANITAS S.A.S
Name (English)
SANITATION S.A.S.