FTD SARS-COV-2/FLUA/FLUB/HRSV - INVIMA Registration fa3970b590a5bde85962122dd554f623
Access comprehensive regulatory information for FTD SARS-COV-2/FLUA/FLUB/HRSV (FTD SARS-COV-2/FLUA/FLUB/HRSV) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID fa3970b590a5bde85962122dd554f623 and manufactured by SIEMENS HEALTHCARE S.A.S.
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.
ES UN ENSAYO SEMIAUTOMATIZADO DE PCR EN TIEMPO REAL CON TRANSCRIPCIÓN INVERSA PARA LA DETECCIÓN CUALITATIVA IN VITRO Y LA DIFERENCIACION DEL CORONAVIRUS 2 DEL SINDROME RESPIRATORIO GRAVE (SARS-COV-2;GENES ORF1AB Y N), EL VIRUS DE LA GRIPE A (IAV), EL VIRUS DE LA GRIPE B (IBV) Y EL ARN DEL VIRUS RESPIRATORIO SINCITIAL HUMANO A Y B (HRSV A Y B) EN MUESTRAS DE HISOPOS NASOFARINGEOS EN UN MEDIO DE TRANSPORTE VIRAL OBTENIDAS DE INDIVIDUOS CON SEÑALES Y SINTOMAS DE INFECCIONES RESPIRATORIAS. LA PRUEBA ESTA DISEÑADA COMO UNA HERRAMIENTA EN EL DIAGNOSTICO DIFERENCIAL DE SARS-COV-2,IAV,IBV YHRSV A Y B EN HUMANOS. EL KIT ESTA DISEÑADO PARA USO PROFESIONAL Y PERSONAL DE LABORATORIO CON LA DEBIDA FORMACION EN PRUEBAS PCR EN TIEMPO REAL EN UN LABORATORIO DE BIOSEGURIDAD DE NIVEL 2 O EQUIVALENTE SEGUN LA NORMATIVA LOCAL. PARA USO DIAGNOSTICO IN VITRO.
IT IS A SEMI-AUTOMATED REAL-TIME PCR ASSAY WITH REVERSE TRANSCRIPTION FOR THE QUALITATIVE IN VITRO DETECTION AND DIFFERENTIATION OF SEVERE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2; GENES ORF1AB AND N), INFLUENZA A VIRUS (IAV), INFLUENZA B VIRUS (IBV), AND HUMAN RESPIRATORY SYNCYTIAL VIRUS A AND B RNA (HRSV A AND B) IN NASOPHARYNGEAL SWAB SAMPLES IN A VIRAL TRANSPORT MEDIUM OBTAINED FROM INDIVIDUALS WITH SIGNS AND SYMPTOMS OF RESPIRATORY INFECTIONS. THE TEST IS DESIGNED AS A TOOL IN THE DIFFERENTIAL DIAGNOSIS OF SARS-COV-2, IAV, IBV YHRSV A and B in humans. THE KIT IS DESIGNED FOR PROFESSIONAL USE AND LABORATORY PERSONNEL WITH PROPER TRAINING IN REAL-TIME PCR TESTING IN A BIOSAFETY LEVEL 2 LABORATORY OR EQUIVALENT ACCORDING TO LOCAL REGULATIONS. FOR IN VITRO DIAGNOSTIC USE.