HCV TEST - COBAS 4800 SYSTEM - COFEPRIS Registration 204R2022 SSA
Access comprehensive regulatory information for HCV TEST - COBAS 4800 SYSTEM (HCV TEST - COBAS 4800 SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 204R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on March 14, 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® HCV ES UNA PRUEBA DE AMPLIFICACIÓN DEÁCIDOSNUCLEICOSIN VITROPARA LA DETECCIÓN YLACUANTIFICACIÓNDELARNDELVIRUSDELAHEPATITISC(VHC), EN PLASMA HUMANO CONSERVADO EN EDTA OSUERODEPACIENTESINFECTADOSCONELVHC. AGENTEDE DIAGNÓSTICO PARA USO IN VITRO. PARA USOEXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETES.
COBAS® HCV IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE DETECTION AND QUANTIFICATION OF HEPATITIS VIRUS (HCV) RNA IN HUMAN PLASMA PRESERVED IN EDTA OR SERUM FROM HCV-INFECTED PATIENTS. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL LABORATORIES OR CABINETS ONLY.