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TOTAL PSA DIAMETRA - INVIMA Registration d5f20d3e3157cb24955ef6ee16bdb2ef

Access comprehensive regulatory information for TOTAL PSA DIAMETRA (TOTAL PSA DIAMETRA) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID d5f20d3e3157cb24955ef6ee16bdb2ef and manufactured by BIOLORE LTDA. The device was registered on January 03, 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
d5f20d3e3157cb24955ef6ee16bdb2ef
TOTAL PSA DIAMETRA
INVIMA Analysis ID: d5f20d3e3157cb24955ef6ee16bdb2ef
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Product Use / Uso del Producto
Spanish

EL KIT DIAMETRA TOTAL PSA SE UTILIZA PARA LA_x000D_ DETERMINACIร“N CUANTITATIVA DEL ANTรGENO _x000D_ PROSTรTICO ESPECรFICO EN SUERO O PLASMA (OBTENIDO _x000D_ CON EL USO DE HEPARINA, CITRATO O EDTA) HUMANO. _x000D_ LA CUANTIFICACIร“N DE LOS NIVELES DE PSA TOTAL SE_x000D_ UTILIZA, EN LOS HOMBRES, PARA ESTIMAR EL RIESGO DE _x000D_ UN CARCINOMA PROSTรTICO EN CONJUNTO CON LA _x000D_ Tร‰CNICA DEL TACTO PROSTรTICO O BIEN PARA _x000D_ MONITOREAR LA EFICIENCIA DEL TRATAMIENTO EN _x000D_ PACIENTES CON CARCINOMA DE LA PRร“STATA.

English

THE DIAMETRA TOTAL PSA KIT IS USED FOR LA_x000D_ QUANTITATIVE DETERMINATION OF ANTIGEN _x000D_ PROSTATE-SPECIFIC SERUM OR PLASMA (OBTAINED _x000D_ WITH THE USE OF HUMAN HEPARIN, CITRATE OR EDTA). _x000D_ QUANTIFICATION OF TOTAL PSA LEVELS SE_x000D_ IT USES, IN MEN, TO ESTIMATE THE RISK OF _x000D_ A PROSTATIC CARCINOMA IN CONJUNCTION WITH THE _x000D_ PROSTATIC TOUCH TECHNIQUE OR FOR _x000D_ MONITOR THE EFFICIENCY OF TREATMENT IN _x000D_ PATIENTS WITH CARCINOMA OF THE PROSTATE.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
d5f20d3e3157cb24955ef6ee16bdb2ef
Expire Date
January 03, 2033
Authorized Company / Fabricante
Name (Spanish)
BIOLORE LTDA
Name (English)
BIOLORE LTDA