COBAS® HCV GT - COFEPRIS Registration 1806R2021 SSA
Access comprehensive regulatory information for COBAS® HCV GT (COBAS® HCV GT) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1806R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on August 11, 2021.
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.
LAPRUEBACOBAS®HCVGTESUNAPRUEBADEAMPLIFICACIÓNDEÁCIDOSNUCLEICOSINVITROPARALAIDENTIFICACIÓNCUALITATIVADELOSGENOTIPOS1-6YLOSSUBTIPOSAYBDELGENOTIPO1DELVIRUSDELAHEPATITISC(VHC) ENPLASMAOSUERO HUMANODESUJETOS AFECTADOS POR UNA INFECCIÓNCRÓNICA POR VHC MEDIANTE EL COBAS®4800SYSTEM:ELCOBASX480INSTRUMENTPARA EL PROCESAMIENTO AUTOMATIZADODEMUESTRASYELCOBASZ480ANALYZERPARA LA AMPLIFICACIÓN Y LA DETECCIÓNAUTOMATIZADAS.
THE COBAS®HCGT TEST IS A NUCLEIC ACID AMPLIFICATION TEST FOR QUALITATIVE IDENTIFICATION OF GENOTYPES1-6 AND THE TICK TYPE 1 SUBTYPE OF HEPATITIS VIRUS (HCV) IN HUMAN PLASMA OF SUBJECTS AFFECTED BY CHRONIC HCV INFECTION USING THE COBAS®4800SYSTEM:ELCOBASX480INSTRUMENT FOR AUTOMATED SAMPLE PROCESSING AND ELCOBASZ480ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION.