COBAS® MTB-RIF/INH. - COFEPRIS Registration 537R2021 SSA
Access comprehensive regulatory information for COBAS® MTB-RIF/INH. (COBAS® MTB-RIF/INH.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 537R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on March 26, 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®MTB-RIF/INHPARAUSOENLOSCOBAS®6800/8800SYSTEMSESUNAPRUEBA DE DIAGNÓSTICO IN VITROCUALITATIVAYAUTOMATIZADAQUEUTILIZALAREACCIÓNENCADENADELAPOLIMERASA(PCR) PARA LA DETECCIÓN DIRECTA DE LARESISTENCIA A LA RIFAMPICINA ASOCIADACON MUTACIONES DEL GEN RPOB Y DELARESISTENCIAALAISONIAZIDAASOCIADACONLASMUTACIONESDELOSGENESKATGEINHADE MYCOBACTERIUM TUBERCULOSIS ENMUESTRAS RESPIRATORIAS HUMANAS.
THE COBAS®MTB-RIF/INH TEST FOR USE IN THE COBAS®6800/8800SYSTEMS IS A QUALITATIVE AND AUTOMATED IN VITRO DIAGNOSTIC TEST USING APOLIMERASE CHAIN REACTION (PCR) FOR THE DIRECT DETECTION OF RIFAMPICIN RESISTANCE ASSOCIATED WITH RPOB GENE MUTATIONS AND RESISTANCE TO AISONIAZID ASSOCIATED WITH MUTATIONS OF THE KATGEINHADE MYCOBACTERIUM TUBERCULOSIS GENES IN HUMAN RESPIRATORY SAMPLES.