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PLATELIA ASPERGILLUS AG - INVIMA Registration ed1f8e2e3996bf6efd3c14fa285dcd3b

Access comprehensive regulatory information for PLATELIA ASPERGILLUS AG (PLATELIA ASPERGILLUS AG ) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID ed1f8e2e3996bf6efd3c14fa285dcd3b and manufactured by QUIK "QUALITY IS THE KEY" S.A.S.. The device was registered on January 19, 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
ed1f8e2e3996bf6efd3c14fa285dcd3b
PLATELIA ASPERGILLUS AG
INVIMA Analysis ID: ed1f8e2e3996bf6efd3c14fa285dcd3b
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Product Use / Uso del Producto
Spanish

LA PRUEBA PLATELIA ASPERGILLUS AG ES UN ENSAYO _x000D_ INMUNOENZIMÁTICO SEMICUANTITATIVO EN MICROPLACA_x000D_ DE TIPO SÁNDWICH PARA LA DETECCIÓN DEL ANTÍGENO _x000D_ GALACTOMANANO DE ASPERGILLUS EN MUESTRAS DE _x000D_ SUERO DE PACIENTES ADULTOS Y PEDIÁTRICOS Y EN _x000D_ MUESTRAS DE LÍQUIDO DE LAVADO BRONCOALVEOLAR _x000D_ (LBA). PLATELIA ASPERGILLUS AG ES UNA PRUEBA QUE, _x000D_ CUANDO SE UTILIZA JUNTO CON OTROS PROCEDIMIENTOS _x000D_ DE DIAGNÓSTICO, COMO EL CULTIVO MICROBIOLÓGICO,_x000D_ EL EXAMEN HISTOLÓGICO DE LAS MUESTRAS DE BIOPSIA Y_x000D_ LAS PRUEBAS RADIOGRÁFICAS, PUEDE SERVIR DE AYUDA _x000D_ EN EL DIAGNÓSTICO DE LA ASPERGILOSIS INVASIVA, _x000D_ ESPECIALMENTE EN EL CASO DE PACIENTES _x000D_ NEUTROPÉNICOS O TRATADOS CON INMUNOSUPRESORES _x000D_ Y CORTICOSTEROIDES. LA PRUEBA PLATELIA ASPERGILLUS_x000D_ AG TAMBIÉN PUEDE UTILIZARSE COMO AYUDA PARA EL _x000D_ SEGUIMIENTO DE LA EFICACIA DELTRATAMIENTO _x000D_ ANTIFÚNGICO EN FUNCIÓN DE LA EVOLUCIÓN DEL ÍNDICE _x000D_ DE GALACTOMANANO. LA PRUEBA PLATELIA ASPERGILLUS AG PUEDE _x000D_ UTILIZARSE MANUALMENTE O EN SISTEMAS _x000D_ AUTOMATIZADOS DE MICROPLACAS.

English

THE PLATELIA ASPERGILLUS AG TEST IS A _x000D_ TEST SEMI-QUANTITATIVE IMMUNOENZYMATIC IN MICROPLACA_x000D_ SANDWICH TYPE FOR THE DETECTION OF ANTIGEN _x000D_ ASPERGILLUS GALACTOMANNAN IN _x000D_ SAMPLES SERUM FROM ADULT AND PEDIATRIC PATIENTS AND IN _x000D_ BRONCHOALVEOLAR LAVAGE FLUID SAMPLES _x000D_ (LBA). PLATELIA ASPERGILLUS AG IS A TEST THAT, _x000D_ WHEN USED IN CONJUNCTION WITH OTHER PROCEDURES _x000D_ DIAGNOSTIC, SUCH AS MICROBIOLOGICAL CULTURE_x000D_ HISTOLOGICAL EXAMINATION OF BIOPSY SAMPLES Y_x000D_ RADIOGRAPHIC TESTS CAN HELP _x000D_ IN DIAGNOSING INVASIVE ASPERGILLOSIS, _x000D_ ESPECIALLY IN THE CASE OF PATIENTS _x000D_ NEUTROPENIC OR TREATED WITH IMMUNOSUPPRESSANTS _x000D_ AND CORTICOSTEROIDS. THE PLATELIA ASPERGILLUS_x000D_ TEST AG CAN ALSO BE USED AS A _x000D_ AID MONITORING THE EFFECTIVENESS OF TREATMENT _x000D_ ANTIFUNGAL DEPENDING ON THE EVOLUTION OF THE _x000D_ INDEX GALACTOMANNAN. THE PLATELIA ASPERGILLUS AG TEST CAN _x000D_ USED MANUALLY OR ON _x000D_ SYSTEMS AUTOMATED MICROPLATES.

Device Classification
Risk Class / Clase de Riesgo
II
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
ed1f8e2e3996bf6efd3c14fa285dcd3b
Expire Date
January 19, 2033
Authorized Company / Fabricante
Name (English)
QUIK "QUALITY IS THE KEY" S.A.S.