COBAS® HIV-1 ROCHE - COFEPRIS Registration 2097R2021 SSA
Access comprehensive regulatory information for COBAS® HIV-1 ROCHE (COBAS® HIV-1 ROCHE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2097R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on October 12, 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® HIV-1 ES UNA PRUEBA DEAMPLIFICACIÓN IN VITRO DE ÁCIDOSNUCLEICOS PARA LA CUANTIFICACIÓN DELVIRUSDELAINMUNODEFICIENCIAHUMANATIPO1(VIH-1)ENPLASMACONSERVADOASÍCOMOPARALADETECCIÓNCUALITATIVADELVIH-1 EN MUESTRAS DE SANGRE SECA DEPERSONASCONVIH-1,INCLUIDOSBEBÉSDEMADRESCONVIH-1.ESTAPRUEBASEEMPLEAJUNTO CON DATOS CLÍNICOS U OTROSMARCADORES DE LABORATORIO DE LAEVOLUCIÓN DE LA ENFERMEDAD, PARA ELSEGUIMIENTO CLÍNICO DE LOS PACIENTESINFECTADOS POR EL VIH-1. EMPL
COBAS® HIV-1 IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTIFICATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1(HIV-1) IN PRESERVED PLASMA AS WELL AS FOR THE QUALITATIVE DETECTION OF HIV-1 IN DRIED BLOOD SAMPLES OF CONVIH-1 PEOPLE, INCLUDING BABIES OF CONVIH-1 MOTHERS. THIS TEST IS USED, TOGETHER WITH CLINICAL DATA OR OTHER LABORATORY MARKERS OF DISEASE PROGRESSION, FOR CLINICAL FOLLOW-UP OF PATIENTS INFECTED WITH HIV-1. EMPL