COBAS MTB - COFEPRIS Registration 589R2021 SSA
Access comprehensive regulatory information for COBAS MTB (COBAS MTB) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 589R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on March 31, 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.
COBAS MTB ES UNA PRUEBA CUALITATIVAAUTOMATIZADA DE DIAGNÓSTICO IN VITROQUEUTILIZALAREACCIÓNENCADENADELAPOLIMERASA(PCR)ATIEMPOREALPARALADETECCIÓNDIRECTADEADNDELCOMPLEJOMYCOBACTERIUMTUBERCULOSIS(MTBC)ENMUESTRAS RESPIRATORIAS HUMANAS ENFROTIS POSITIVOS O NEGATIVOS ABACILOSÁCIDO-ALCOHOL RESISTENTES (BAAR),INCLUIDAS MUESTRAS DE ESPUTO SINPROCESAR,ASÍCOMOMUESTRASDEESPUTOY LAVADO BRONCOALVEOLAR (LBA)DIGERIDASYDESCONTAMINADAS(TRATADASCON N-ACETIL-L-CISTEÍNA/NAO
COBAS MTB IS AN AUTOMATED QUALITATIVE IN VITRO DIAGNOSTIC TEST USING REAL-TIME APOLIMERASE CHAIN REACTION (PCR) FOR DIRECT DETECTIONOF MYCOBACTERIUM TUBERCULOSIS COMPLEX (MTBC) IN HUMAN RESPIRATORY SAMPLES IN POSITIVE OR NEGATIVE ABACYLOSACID-FAST (ABB) SMEARS,INCLUDING UNPROCESSED SPUTUM SAMPLES,AS WELL AS DIGESTED AND DECONTAMINATED BRONCHOALVEOLAR LAVAGE (BL)SPUTUM AND LAVAGE SAMPLES (TREATED WITH N-ACETYL-L-CYSTEINE/NAO)