TISSUE PRETREATMENT KIT - INVIMA Registration 61afd47896cd8f9df17ff06df3707a0f
Access comprehensive regulatory information for TISSUE PRETREATMENT KIT (TISSUE PRETREATMENT KIT) in the Colombia medical device market through Pure Global AI's free database. This medical device is registered under INVIMA analysis ID 61afd47896cd8f9df17ff06df3707a0f and manufactured by LABTRONICS S.A.S.. The device was registered on September 22, 2032.
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.
LOS PRODUCTOS MENCIONADOS ANTERIORMENTE SON ÚNICAMENTE PARA USO GENERAL DE LABORATORIO. ESTOS NO ESTÁN ETIQUETADOS O DESTINADOS DE OTRO MODO A UNA APLICACIÓN DE DIAGNÓSTICO ESPECÍFICA (PCA 003, PCA 005, PCN 002). (LPS100) PARA SU USO EN EL PRETRATAMIENTO TÉRMICO Y LA DIGESTIÓN ENZIMÁTICA DE TEJIDO FIJADO EN FORMOL E INCLUIDO EN PARAFINA (FFPE) ANTES DE SOMETERLO A DETECCIÓN POR HIBRIDACIÓN IN SITU CON FLUORESCENCIA (FISH) O HIBRIDACIÓN IN SITU CROMOGÉNICA (CISH). EL PRODUCTO ESTÁ DESTINADO A SU USO GENERAL EN LABORATORIO O EN UNA PRUEBA DESARROLLADA POR UN LABORATORIO (LDT). SI SE UTILIZA COMO PARTE DE UNA LDT, LA VALIDACIÓN DE ESTA ANTES DE UTILIZARLA EN UN ENTORNO CLÍNICO CORRESPONDERÁ AL LABORATORIO QUE LA DESARROLLE.
THE PRODUCTS MENTIONED ABOVE ARE FOR GENERAL LABORATORY USE ONLY. THESE ARE NOT LABELED OR OTHERWISE INTENDED FOR A SPECIFIC DIAGNOSTIC APPLICATION (PCA 003, PCA 005, PCN 002). (LPS100) FOR USE IN HEAT PRETREATMENT AND ENZYMATIC DIGESTION OF FORMALIN-FIXED, PARAFFIN-INCLUDED TISSUE (FFPE) PRIOR TO DETECTION BY FLUORESCENCE IN SITU HYBRIDIZATION (FISH) OR CHROMOGENIC IN SITU HYBRIDIZATION (CISH). THE PRODUCT IS INTENDED FOR GENERAL USE IN THE LABORATORY OR IN A LABORATORY-DEVELOPED TEST (LDT). IF USED AS PART OF AN LDT, VALIDATION OF THE LDT BEFORE USE IN A CLINICAL SETTING WILL BE THE RESPONSIBILITY OF THE LABORATORY DEVELOPING IT.