COBAS® MAI. - COFEPRIS Registration 516R2021 SSA
Access comprehensive regulatory information for COBAS® MAI. (COBAS® NEVER.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 516R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on March 25, 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® MAI ES UNA PRUEBA CUALITATIVAAUTOMATIZADA DE DIAGNÓSTICO IN VITROQUEUTILIZALAREACCIÓNENCADENADELAPOLIMERASA(PCR)ATIEMPOREALPARALADETECCIÓN DIRECTA Y LA DIFERENCIACIÓNDE ADN DE MYCOBACTERIUM AVIUM YMYCOBACTERIUM INTRACELLULARE ENMUESTRAS RESPIRATORIAS HUMANAS,INCLUIDAS MUESTRAS DE ESPUTO SINPROCESAR INACTIVADAS, ASÍ COMOMUESTRAS DE ESPUTO INACTIVADASDIGERIDASYDESCONTAMINADAS(TRATADASCON N-ACETIL-L-CISTEÍNA/NAOH [NALC-NAOH]) Y MUESTRAS DE LAVADOBRONCOALVEOLAR (L
COBAS® MAI IS AN AUTOMATED QUALITATIVE IN VITRO DIAGNOSTIC TEST USING REAL-TIME APOLIMERASE CHAIN REACTION (PCR) FOR DIRECT DETECTION AND DIFFERENTIATION OF MYCOBACTERIUM AVIUM AND MYCOBACTERIUM INTRACELLULARE DNA IN HUMAN RESPIRATORY SAMPLES, INCLUDING INACTIVATED RAW SPUTUM SAMPLES, AS WELL AS DIGESTED AND DECONTAMINATED INACTIVATED SPUTUM SAMPLES (TREATED WITH N-ACETYL-L-CYSTEINE/NAOH [NALC-NAOH]) AND BRONCHOALVEOLAR LAVAGE SAMPLES (L