STAT-NAT®HSV-1&2 FLEX - INVIMA Registration 330c3e127b7cf2aa64cf6958486b2c43
Access comprehensive regulatory information for STAT-NAT®HSV-1&2 FLEX (STAT-NAT®HSV-1&2 FLEX) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 330c3e127b7cf2aa64cf6958486b2c43 and manufactured by ROCHEM BIOCARE COLOMBIA 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.
EL STAT-NAT® HSV-1&2 FLEX ES UN ENSAYO DE AMPLIFICACIÓN DE _x000D_ ÁCIDOS NUCLEICOS IN VITRO PARA LA DETECCIÓN Y LA CUANTIFICACIÓN DEL _x000D_ ADN DEL HERPES SIMPLEX VIRUS TYPE 1 (HSV-1, HUMAN ALPHAHERPES-_x000D_ VIRUS 1), Y/O DEL ADN DEL HERPES SIMPLEX VIRUS TYPE 2 (HSV-2, _x000D_ HUMAN ALPHAHERPESVIRUS 2), EXTRAÍDO DE MUESTRAS HUMANAS1,2,3. _x000D_ EL ENSAYO SE BASA EN LA REAL-TIME PCR Y ES COMPATIBLE CON _x000D_ SISTEMAS MANUALES, SEMIAUTOMÁTICOS Y AUTOMÁTICOS. EL ENSAYO ESTÁ _x000D_ DESTINADO A UTILIZARSE COMO AYUDA EN EL DIAGNÓSTICO DE LAS INFEC-_x000D_ CIONES POR EL HSV-1& 2. SÓLO PARA USO PROFESIONAL DE LABORATORIO.
THE STAT-NAT® HSV-1&2 FLEX IS A _x000D_ AMPLIFICATION TEST IN VITRO NUCLEIC ACIDS FOR THE DETECTION AND QUANTIFICATION OF _x000D_ HERPES SIMPLEX VIRUS TYPE 1 DNA (HSV-1, HUMAN ALPHAHERPES-_x000D_ VIRUS 1), AND/OR HERPES SIMPLEX VIRUS TYPE 2 DNA (HSV-2, _x000D_ HUMAN ALPHAHERPESVIRUS 2), EXTRACTED FROM SAMPLES HUMANAS1,2,3. _x000D_ THE ASSAY IS BASED ON REAL-TIME PCR AND IS COMPATIBLE WITH _x000D_ MANUAL, SEMI-AUTOMATIC AND AUTOMATIC SYSTEMS. THE TRIAL IS _x000D_ INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF INFECTIOUS DISEASES _x000D_ BY THE HSV-1& 2. FOR PROFESSIONAL LABORATORY USE ONLY.