SURESELECT CANCER CGP ASSAY KITS DNA+RNA - INVIMA Registration 4209e742f7fe51498fe4dcb62696168f
Access comprehensive regulatory information for SURESELECT CANCER CGP ASSAY KITS DNA+RNA (SURESELECT CANCER CGP ASSAY KITS DNA+RNA) in the Colombia medical device market through Pure Global AI's free database. This I medical device is registered under INVIMA analysis ID 4209e742f7fe51498fe4dcb62696168f and manufactured by GENCELL PHARMA SAS. The device was registered on March 01, 2034.
This page provides complete registration details including product type (REACTIVOS IN VITRO), 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.
SÓLO PARA USO EN INVESTIGACIÓN._x000D_ 5. SURESELECT CANCER CGP ASSAY KITS DNA+RNA: EL _x000D_ ENSAYO DE PERFIL GENÓMICO INTEGRAL DEL CÁNCER _x000D_ SURESELECT (CGP) ES UNA SOLUCIÓN DE SECUENCIACIÓN _x000D_ DE PRÓXIMA GENERACIÓN (NGS) DIRIGIDA QUE PERMITE LA_x000D_ INTERROGACIÓN DE REGIONES GENÓMICAS Y _x000D_ TRANSCRIPTÓMICAS RELEVANTES EN TUMORES SÓLIDOS _x000D_ PARA UNA VARIEDAD DE CARACTERÍSTICAS, INCLUIDAS LAS_x000D_ ENUMERADAS A CONTINUACIÓN. EL ENSAYO DE PERFIL _x000D_ GENÓMICO INTEGRAL DEL CÁNCER SURESELECT ADMITE EL_x000D_ ANÁLISIS DE MUESTRAS DE ADN Y ARN AISLADAS DE _x000D_ MUESTRAS FRESCAS O FRESCAS CONGELADAS O _x000D_ EXTRAÍDAS DE TEJIDOS FIJADOS EN FORMALINA E _x000D_ INCLUIDOS EN PARAFINA (FFPE). EL ENSAYO ESTÁ_x000D_ OPTIMIZADO PARA CANTIDADES DE ENTRADA DE MUESTRA _x000D_ DE 50 NG DE ADN GENÓMICO O 50 NG DE ARN TOTAL. PARA_x000D_ MUESTRAS FFPE DE BAJA CALIDAD, EL RENDIMIENTO DEL _x000D_ ENSAYO PUEDE MEJORAR AUMENTANDO LA CANTIDAD DE_x000D_ ENTRADA DE ADN O ARN HASTA 200 NG. EL SISTEMA _x000D_ SURESELECT XT HS2 ADMITE EL USO DE 10–200 NG DE ADN_x000D_ O ARN DE ENTRADA; SIN EMBARGO, EL USO DE ENTRADA _x000D_ <50 NG PARA EL ENSAYO DE PERFIL GENÓMICO INTEGRAL _x000D_ DEL CÁNCER SURESELECT PUEDE RESULTAR EN UNA _x000D_ COBERTURA DE OBJETIVO MÁS BAJA Y UNA DETECCIÓN _x000D_ REDUCIDA DE VARIANTES DE BAJA FRECUENCIA.
FOR USE IN INVESTIGACIÓN._x000D_ ONLY 5. SURESELECT CANCER CGP ASSAY DNA+RNA KITS: THE _x000D_ COMPREHENSIVE CANCER GENOMIC PROFILING ASSAY _x000D_ SURESELECT (CGP) IS A _x000D_ SEQUENCING SOLUTION DIRECTED NEXT-GENERATION (NGS) THAT ENABLES LA_x000D_ INTERROGATION OF GENOMIC REGIONS AND _x000D_ RELEVANT TRANSCRIPTOMICS IN SOLID TUMORS _x000D_ FOR A VARIETY OF FEATURES, INCLUDING LAS_x000D_ LISTED BELOW. THE PROFILE ESSAY _x000D_ SURESELECT COMPREHENSIVE CANCER GENOMICS SUPPORTS EL_x000D_ ANALYSIS OF DNA AND RNA SAMPLES ISOLATED FROM _x000D_ FRESH OR FRESH SAMPLES FROZEN OR _x000D_ EXTRACTED FROM FORMALIN-FIXED FABRICS AND _x000D_ INCLUDED IN PARAFFIN (FFPE). THE ESTÁ_x000D_ ESSAY OPTIMIZED FOR SAMPLE INPUT QUANTITIES _x000D_ OF 50 NG OF GENOMIC DNA OR 50 NG OF TOTAL RNA. PARA_x000D_ LOW-QUALITY FFPE SAMPLES, _x000D_ PERFORMANCE ASSAY CAN BE IMPROVED BY INCREASING THE AMOUNT DE_x000D_ DNA OR RNA INPUT UP TO 200 NG. THE _x000D_ SYSTEM SURESELECT XT HS2 SUPPORTS 10–200 NG ADN_x000D_ O INPUT RNA; HOWEVER, THE USE OF INPUT _x000D_ <50 NG FOR THE COMPREHENSIVE GENOMIC PROFILING ASSAY _x000D_ OF SURESELECT CANCER CAN RESULT IN A _x000D_ LOWER TARGET COVERAGE AND _x000D_ DETECTION REDUCED OF LOW-FREQUENCY VARIANTS.