COBAS® CHIKV/DENV. - COFEPRIS Registration 701R2021 SSA
Access comprehensive regulatory information for COBAS® CHIKV/DENV. (COBAS® CHIKV/DENV.) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 701R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on April 21, 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.
O MIOCARDITELCOBAS®CHIKV/DENVPARAUSOENLOSCOBAS®6800/8800SYSTEMSESUNAPRUEBACUALITATIVA IN VITRO PARA LADETECCIÓNDIRECTADELARNDELVIRUSCHIKUNGUNYA(CHIKV)YELARNDELOSSEROTIPOS1-4DELVIRUS DEL DENGUE (DENV) EN PLASMAHUMANO. ESTA PRUEBA SE HA DISEÑADOCOMOCRIBADOINDEPENDIENTEDEARNDELCHIKV O ARN DEL DENV EN MUESTRAS DEDONANTES O COMO CRIBADO SIMULTÁNEODEARNDELCHIKVYDELDENVENPLASMAPROCEDENTE DE DONANTES DE SANGREINDIVIDUALES, INCLUYENDO DONANTES DESANGRE TOTAL, COMP
O MIOCARDITELCOBAS CHIKV/DENV FOR USE IN THE COBAS®®6800/8800SYSTEMS IS A QUALITATIVE IN VITRO TEST FOR THE DIRECT DETECTION OF CHIKUNGUNYA(CHIKV)VIRUS RNA AND DENGUE VIRUS (DENV) EROTYPES 1-4 IN HUMAN PLASMA. THIS TEST HAS BEEN DESIGNED AS INDEPENDENT SCREENING OF THE CHIKV OR DENV RNA IN DONOR SAMPLES OR AS SIMULTANEOUS SCREENING OF CHIKVYDELDENVENPLASMA FROM INDIVIDUAL BLOOD DONORS, INCLUDING WHOLE BLOOD DONORS, COMP