CFX96TM DX SYSTEM - COFEPRIS Registration 136E2021 SSA
Access comprehensive regulatory information for CFX96TM DX SYSTEM (CFX96TM DX SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 136E2021 SSA and manufactured by BIO-RAD, S.A.. The device was registered on February 04, 2021.
This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
LOSSISTEMASCFX96™DXSYSTEMYCFX96™DEEP WELL DX SYSTEM ESTÁN PREVISTOSPARA REALIZAR PCR BASADO ENFLUORESCENCIA PARA DETECTAR YCUANTIFICAR SECUENCIAS DE ÁCIDONUCLEICO, Y PARA USARSE COMOHERRAMIENTAS DE DIAGNÓSTICO IN VITROPORPARTEDETÉCNICOSDELABORATORIOCUALIFICADOS. LOS SISTEMAS ESTÁNCONCEBIDOSPARASUUSOCONPRUEBASDEDIAGNÓSTICO DE ÁCIDO NUCLEICO DETERCEROS,FABRICADASYETIQUETADASCONFINES DE DIAGNÓSTICO.
THE CFX96 DXSYSTEM and CFX96™™DEEP WELL DX SYSTEM ARE INTENDED TO PERFORM FLUORESCENCE-BASED PCR TO DETECT AND QUANTIFY NUCLEIC ACID SEQUENCES, AND TO BE USED AS IN VITRO DIAGNOSTIC TOOLS BY QUALIFIED LABORATORY TECHNICIANS. THE SYSTEMS ARE DESIGNED FOR USE WITH THIRD-PARTY NUCLEIC ACID DIAGNOSTIC TESTS, MANUFACTURED AND LABELLEDDIAGNOSTIC CONFINES.