AUTOMATIC URINALYSIS SYSTEM - SISTEMA DE ANÁLISIS DE ORINA AUTOMÁTICO - INVIMA Registration 598a60c29205bc7f233760bde6392cd4
Access comprehensive regulatory information for AUTOMATIC URINALYSIS SYSTEM - SISTEMA DE ANÁLISIS DE ORINA AUTOMÁTICO (AUTOMATIC URINALYSIS SYSTEM - SISTEMA DE ANÁLISIS DE ORINA AUTOMÁTICO) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 598a60c29205bc7f233760bde6392cd4 and manufactured by MINDRAY MEDICAL COLOMBIA S.A.S.. The device was registered on May 06, 2034.
This page provides complete registration details including product type (SURGICAL DOCTOR), 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.
EL SISTEMA AUTOMÁTICO DE ANÁLISIS DE ORINA ES UN DISPOSITIVO DE DIAGNÓSTICO IN VITRO UTILIZADO PARA REALIZAR PRUEBAS CUANTITATIVAS EN ORINA HUMANA EN ENTORNOS DE LABORATORIO. CLÍNICAMENTE, EL ANALIZADOR IDENTIFICA Y ANALIZA LOS ELEMENTOS FORMADOS EN LA ORINA HUMANA, INCLUIDOS LOS ERITROCITOS, LOS LEUCOCITOS, LOS LEUCOCITOS AGLOMERADOS, LAS BACTERIAS, LAS LEVADURAS, LAS CÉLULAS EPITELIALES ESCAMOSAS, LAS CÉLULAS EPITELIALES NO ESCAMOSAS, LOS CRISTALES, LOS CILINDROS HIALINOS, EL CILINDRO NO CLASIFICADO, LOS FILAMENTOS MUCOIDES, EL SEMEN, LOS MICROCOCOS, LOS BACILOS, LOS CRISTALES DE OXALATO CÁLCICO MONOHIDRATADO, LOS CRISTALES DE OXALATO CÁLCICO DIHIDRATADO, EL CRISTAL DE ÁCIDO ÚRICO Y EL CRISTAL DE FOSFATO TRIPLE. EL SISTEMA TAMBIÉN PUEDE UTILIZARSE PARA PRUEBAS SEMICUANTITATIVAS O CUALITATIVAS DE ORINA HUMANA CON TIRAS DE PRUEBA PARA EL ANÁLISIS DE ORINA. ES ADECUADO PARA REALIZAR EXÁMENES CLÍNICOS RUTINARIOS DE ORINA. LAS PRUEBAS INCLUYEN: LEUCOCITOS, NITRITOS, UROBILINÓGENO, PROTEÍNAS, POTENCIAL DE HIDRÓGENO, SANGRE, GRAVEDAD ESPECÍFICA, CETONA, BILIRRUBINA, GLUCOSA, VITAMINA C, MICROALBÚMINA, CREATININA, CALCIO, COLOR Y TURBIEDAD. _x000D_ _x000D_ _x000D_
THE AUTOMATIC URINALYSIS SYSTEM IS AN IN VITRO DIAGNOSTIC DEVICE USED TO PERFORM QUANTITATIVE TESTS ON HUMAN URINE IN LABORATORY SETTINGS. CLINICALLY, THE ANALYZER IDENTIFIES AND ANALYZES ELEMENTS FORMED IN HUMAN URINE, INCLUDING ERYTHROCYTES, LEUKOCYTES, AGGLOMERATED LEUKOCYTES, BACTERIA, YEAST, SQUAMOUS EPITHELIAL CELLS, NON-SQUAMOUS EPITHELIAL CELLS, CRYSTALS, HYALINE CASTS, UNCLASSIFIED CYLINDER, MUCOID FILAMENTS, SEMEN, MICROCOCCI, BACILLI, CALCIUM OXALATE MONOHYDRATE CRYSTALS, CALCIUM OXALATE DIHYDRATE CRYSTALS, URIC ACID CRYSTAL, AND TRIPLE PHOSPHATE CRYSTAL. THE SYSTEM CAN ALSO BE USED FOR SEMI-QUANTITATIVE OR QUALITATIVE TESTING OF HUMAN URINE WITH TEST STRIPS FOR URINALYSIS. IT IS SUITABLE FOR ROUTINE CLINICAL URINE EXAMINATIONS. TESTS INCLUDE: LEUKOCYTES, NITRITES, UROBILINOGEN, PROTEINS, HYDROGEN POTENTIAL, BLOOD, SPECIFIC GRAVITY, KETONE, BILIRUBIN, GLUCOSE, VITAMIN C, MICROALBUMIN, CREATININE, CALCIUM, COLOR, AND TURBIDITY. _x000D_ _x000D_ _x000D_