PATHVYSION HER-2 DNA PROBE KIT II - INVIMA Registration dc62128598e5f0d6055da2a36eedba04
Access comprehensive regulatory information for PATHVYSION HER-2 DNA PROBE KIT II (PATHVYSION HER-2 DNA PROBE KIT II) in the Colombia medical device market through Pure Global AI's free database. This II medical device is registered under INVIMA analysis ID dc62128598e5f0d6055da2a36eedba04 and manufactured by ABBOTT LABORATORIES DE COLOMBIA S.A.S.. The device was registered on May 22, 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.
PATHVYSION HER-2 DNA PROBE KIT II (PATHVYSION KIT II) SE UTILIZA PARA _x000D_ DETECTAR MEDIANTE LA HIBRIDACIÓN IN SITU POR FLUORESCENCIA (FISH) LA _x000D_ AMPLIFICACIÓN DEL GEN HER-2/NEU EN MUESTRAS HUMANAS DE TEJIDO CON _x000D_ CÁNCER DE MAMA Y GÁSTRICO FIJADAS CON FORMOL Y EMBEBIDAS EN PARAFINA._x000D_ EN EL CÁNCER DE MAMA LOS RESULTADOS OBTENIDOS CON EL PATHVYSION KIT II _x000D_ SE UTILIZAN JUNTO CON LA INFORMACIÓN CLÍNICA Y PATOLÓGICA, ESTA INFORMACIÓN ES UTILIZADA ACTUALMENTE COMO FACTOR PRONÓSTICO EN PACIENTES CON _x000D_ CÁNCER DE MAMA EN ESTADIO II CON GANGLIOS POSITIVOS. EL PATHVYSION KIT II _x000D_ TAMBIÉN ESTÁ INDICADO COMO AYUDA PARA PREDECIR LA SUPERVIVENCIA _x000D_ SIN ENFERMEDAD Y LA SUPERVIVENCIA GLOBAL EN PACIENTES CON CÁNCER DE _x000D_ MAMA EN ESTADIO II CON GANGLIOS POSITIVOS TRATADOS CON QUIMIOTERAPIA _x000D_ ANTINEOPLÁSICA CON CICLOFOSFAMIDA, DOXORRUBICINA Y 5-FLUOROURACILO (CAF). _x000D_ EL PATHVYSION KIT II ESTÁ INDICADO COMO AYUDA EN LA EVALUACIÓN DE _x000D_ PACIENTES CON CÁNCER DE MAMA PARA LOS QUE SE ESTÉ CONSIDERANDO EL _x000D_ TRATAMIENTO CON HERCEPTIN® (TRASTUZUMAB) (CONSULTE EL PROSPECTO DE _x000D_ HERCEPTIN).
PATHVYSION HER-2 DNA PROBE KIT II (PATHVYSION KIT II) IS USED FOR _x000D_ DETECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) FOR _x000D_ AMPLIFICATION OF THE HER-2/NEU GENE IN HUMAN TISSUE SAMPLES WITH _x000D_ BREAST AND GASTRIC CANCER FIXED WITH FORMALDEHYDE AND SOAKED IN PARAFINA._x000D_ IN BREAST CANCER, THE RESULTS OBTAINED WITH THE PATHVYSION KIT II _x000D_ THEY ARE USED TOGETHER WITH CLINICAL AND PATHOLOGICAL INFORMATION, THIS INFORMATION IS CURRENTLY USED AS A PROGNOSTIC FACTOR IN PATIENTS WITH _x000D_ STAGE II NODE-POSITIVE BREAST CANCER. THE PATHVYSION KIT II _x000D_ IT IS ALSO INDICATED AS AN AID TO PREDICT _x000D_ SURVIVAL DISEASE-FREE AND OVERALL SURVIVAL IN PATIENTS WITH _x000D_ CANCER STAGE II NODE-POSITIVE BREAST TREATED WITH CHEMOTHERAPY _x000D_ ANTINEOPLASTIC WITH CYCLOPHOSPHAMIDE, DOXORUBICIN AND 5-FLUOROURACIL (CAF). _x000D_ THE PATHVYSION KIT II IS INDICATED AS AN AID IN THE EVALUATION OF _x000D_ BREAST CANCER PATIENTS FOR WHOM _x000D_ TREATMENT WITH HERCEPTIN® (TRASTUZUMAB) (SEE PACKAGE LEAFLET FOR _x000D_ HERCEPTIN).