ALINITY M BKV AMP KIT - INVIMA Registration 9d6be0eea288ef394396e5a1958ca0cd
Access comprehensive regulatory information for ALINITY M BKV AMP KIT (ALINITY M BKV AMP KIT) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID 9d6be0eea288ef394396e5a1958ca0cd and manufactured by ABBOTT LABORATORIES DE COLOMBIA S.A.S.. The device was registered on April 08, 2034.
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.
ALINITY M BKV ES UN ENSAYO IN VITRO DE AMPLIFICACIÓN _x000D_ DE ÁCIDO NUCLEICO PARA LA CUANTIFICACIÓN DE DNA DE _x000D_ VIRUS BK (VBK) EN PLASMA RECOGIDO CON EDTA Y ORINA _x000D_ ESTABILIZADA EN TAMPÓN DE TRANSPORTE HUMANOS _x000D_ CON EL ANALIZADOR AUTOMATIZADO ALINITY M SYSTEM._x000D_ EN PLASMA RECOGIDO CON EDTA Y ORINA ESTABILIZADA _x000D_ EN TAMPÓN DE TRANSPORTE, EL ENSAYO ALINITY M BKV _x000D_ SE UTILIZA COMO AYUDA EN EL TRATAMIENTO DEL VIRUS _x000D_ BK EN PACIENTES CON TRASPLANTES. EN PACIENTES A LOS_x000D_ QUE SE REALIZA UN SEGUIMIENTO DEL VIRUS BK EN _x000D_ PLASMA RECOGIDO CON EDTA, LAS MEDICIONES SERIADAS _x000D_ DE DNA SE PUEDEN UTILIZAR PARA INDICAR LA NECESIDAD_x000D_ DE REALIZAR POSIBLES CAMBIOS EN EL TRATAMIENTO Y _x000D_ PARA EVALUAR LA RESPUESTA VÍRICA AL TRATAMIENTO._x000D_ LOS RESULTADOS DEL ENSAYO ALINITY M BKV SE DEBEN _x000D_ INTERPRETAR JUNTO CON LOS SIGNOS Y SÍNTOMAS _x000D_ CLÍNICOS, Y OTROS RESULTADOS CLÍNICOS DE _x000D_ LABORATORIO RELEVANTES. LAS DECISIONES SOBRE EL _x000D_ TRATAMIENTO DE LOS PACIENTES NO SE DEBEN BASAR _x000D_ ÚNICAMENTE EN LOS RESULTADOS DEL ANÁLISIS. EL _x000D_ ENSAYO ALINITY M BKV NO SE DEBE UTILIZAR COMO _x000D_ ANÁLISIS DE CRIBADO DE SANGRE O HEMODERIVADOS, _x000D_ CÉLULAS O TEJIDOS HUMANOS NI PRODUCTOS BASADOS _x000D_ EN CÉLULAS O TEJIDOS.
ALINITY M BKV IS AN IN VITRO _x000D_ AMPLIFICATION ASSAY NUCLEIC ACID FOR _x000D_ DNA QUANTIFICATION PLASMA BK VIRUS (BBV) COLLECTED WITH EDTA AND URINE _x000D_ STABILIZED IN HUMAN TRANSPORT BUFFER _x000D_ WITH THE ALINITY M SYSTEM._x000D_ AUTOMATED ANALYZER IN PLASMA COLLECTED WITH EDTA AND STABILIZED URINE _x000D_ IN TRANSPORT BUFFER, THE ALINITY M BKV ASSAY _x000D_ IT IS USED AS AN AID IN THE TREATMENT OF _x000D_ VIRUS BK IN TRANSPLANT PATIENTS. IN PATIENTS AT LOS_x000D_ THAT THE BK VIRUS IS TRACKED IN _x000D_ PLASMA COLLECTED WITH EDTA, SERIAL MEASUREMENTS _x000D_ CAN BE USED TO INDICATE NECESIDAD_x000D_ TO MAKE POSSIBLE CHANGES IN TREATMENT AND _x000D_ TO ASSESS THE VIRAL RESPONSE TO TRATAMIENTO._x000D_ THE RESULTS OF THE ALINITY M BKV ASSAY ARE DUE _x000D_ INTERPRET ALONG WITH SIGNS AND SYMPTOMS _x000D_ CLINICAL FINDINGS, AND OTHER CLINICAL OUTCOMES OF _x000D_ RELEVANT LABORATORIES. DECISIONS ON _x000D_ TREATMENT OF PATIENTS SHOULD NOT BE BASED ON _x000D_ ONLY ON THE RESULTS OF THE ANALYSIS. THE _x000D_ ALINITY M BKV ASSAY SHOULD NOT BE USED AS _x000D_ BLOOD OR BLOOD PRODUCT SCREENING TESTS, _x000D_ HUMAN CELLS OR TISSUES OR PRODUCTS BASED _x000D_ IN CELLS OR TISSUES.