AUTOMATIC LUMINESCENCE INMUNOASSAY ANALYZERS / ANALIZADORES DE INMUNOENSAYO DE LUMINISCENCIA AUTOMÁTICOS - INVIMA Registration 5bcadb90642ecc0e32409ec60616444e
Access comprehensive regulatory information for AUTOMATIC LUMINESCENCE INMUNOASSAY ANALYZERS / ANALIZADORES DE INMUNOENSAYO DE LUMINISCENCIA AUTOMÁTICOS (AUTOMATIC LUMINESCENCE IMMUNOASSAY ANALYZERS) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID 5bcadb90642ecc0e32409ec60616444e and manufactured by BIOLORE LTDA. The device was registered on January 04, 2032.
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.
"INSTRUMENTO TOTALMENTE AUTOMATIZADO QUE UTILIZA UN MÉTODO DE QUIMIOLUMINISCENCIA BASADO EN PEROXIDASA DE RÁBANO PICANTE Y LUMINOL, QUE SE COMBINA CON LOS REACTIVOS DE PRUEBA CORRESPONDIENTES Y SE UTILIZA CLÍNICAMENTE PARA LA PRUEBA CUALITATIVA O CUANTITATIVA DEL ANALITO DE MUESTRAS DE SUERO, PLASMA U ORINA HUMANOS. LOS ELEMENTOS DE PRUEBA INCLUYEN ANTÍGENO ASOCIADO AL TUMOR, HEPATOPATÍA, HORMONAS, ENFERMEDADES INFECCIOSAS, FUNCIÓN INMUNOLÓGICA, AUTOANTICUERPOS, PROTEÍNAS Y PÉPTIDOS, MIOCARDIOPATÍA, CONCENTRACIÓN DE VITAMINAS, AMINOÁCIDOS Y PLASMA Y ALÉRGENOS. ESTÁ DISEÑADO ESTRICTAMENTE PARA USO PROFESIONAL DE DIAGNÓSTICO IN VITRO Y SOLO DEBE USARSE CON EL SISTEMA DE DIAGNÓSTICO AUTORIZADO POR AUTOBIO" _x000D_ _x000D_ _x000D_
"FULLY AUTOMATED INSTRUMENT USING A CHEMILUMINESCENCE METHOD BASED ON HORSERADISH PEROXIDASE AND LUMINOL, WHICH IS COMBINED WITH THE CORRESPONDING TEST REAGENTS AND USED CLINICALLY FOR QUALITATIVE OR QUANTITATIVE ANALYTE TESTING OF HUMAN SERUM, PLASMA OR URINE SAMPLES. TEST ITEMS INCLUDE TUMOR-ASSOCIATED ANTIGEN, LIVER DISEASE, HORMONES, INFECTIOUS DISEASES, IMMUNE FUNCTION, AUTOANTIBODIES, PROTEINS AND PEPTIDES, CARDIOMYOPATHY, CONCENTRATION OF VITAMINS, AMINO ACIDS AND PLASMA AND ALLERGENS. IT IS DESIGNED STRICTLY FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE AND SHOULD ONLY BE USED WITH THE AUTOBIO-AUTHORIZED DIAGNOSTIC SYSTEM." _x000D_ _x000D_ _x000D_