COBAS® HBV ROCHE - COFEPRIS Registration 603R2022 SSA
Access comprehensive regulatory information for COBAS® HBV ROCHE (COBAS® HBV ROCHE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 603R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on July 13, 2022.
This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), 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.
COBAS®HBVESUNAPRUEBADEAMPLIFICACIÓNINVITRODEÁCIDOSNUCLEICOSPARALACUANTIFICACIÓNDELADNDELVIRUSDELAHEPATITISB(VHB)ENPLASMAHUMANOCONSERVADO EN EDTA O SUERO DE PACIENTESINFECTADOSCONELVHB.ESTAPRUEBAESTÁDESTINADAPARA SU USO COMO AYUDA EN LA GESTIÓN DE LOSPACIENTES CON UNA INFECCIÓN CRÓNICA POR VHBSOMETIDOSAUNATERAPIAANTIVÍRICA.LAPRUEBAPUEDEUTILIZARSEPARACUANTIFICARLOSNIVELESDEADNDELVHBINICIALESYDURANTEELTRATAMIENTOPARAVALORARLA RESPUESTA
COBAS®HBVESAN AMPLIFICATION TESTINVITING NUCLEIC ACIDS TO QUANTIFY HEPATITISB(HBV) VIRUS IN HUMAN PLASMA PRESERVED IN EDTA OR SERUM FROM PATIENTS INFECTED WITH HBV. THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HHB INFECTION UNDERGOING ANTIVIRAL THERAPY. The test can be used to quantifythe levels of baseline and during treatment to assess RESPONSE