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COBAS® CMV - COFEPRIS Registration 139R2022 SSA

Access comprehensive regulatory information for COBAS® CMV (COBAS® CMV) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 139R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on February 22, 2022.

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.

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COFEPRIS Official Data
Clase II
139R2022 SSA
COBAS® CMV
COFEPRIS Analysis ID: 139R2022 SSA
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Product Use / Uso del Producto
Spanish

LA PRUEBA COBAS® CMV ES UNA PRUEBA DEAMPLIFICACIÓNDEÁCIDOSNUCLEICOSINVITROPARALAMEDICIÓNCUANTITATIVADELADNDELCITOMEGALOVIRUS(CMV) EN PLASMA HUMANO CONSERVADO EN EDTA.AGENTESDEDIAGNÓSTICOPARAUSOINVITRO.PARAUSOEXCLUSIVO EN LABORATORIOS CLÍNICOS Ó DE GABINETE.

English

THE COBAS® CMV TEST IS A TEST FOR AMPLIFICATION OF NUCLEIC ACIDSINVITROPARALAM QUANTITATIVE ANALYSIS OF CYTOMEGALOVIRUS (CMV) IN HUMAN PLASMA CONSERVED IN EDTA. DIAGNOSTICAGENTSFORUSEINVITRO. FOR EXCLUSIVE USE IN CLINICAL OR CABINET LABORATORIES.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBADEAMPLIFICACIÓNDEÁCIDOS NUCLEICOS PARA LAMEDICIÓN DEL ADN DELCITOMEGALOVIRUS (CMV).
Trade Name (English)
NUCLEIC ACID AMPLIFICATION TEST FOR MEASURING THE DNA OF CYTOMEGALOVIRUS (CMV).
Registration Information
Analysis ID
139R2022 SSA
Registration Date
February 22, 2022
Manufacturer / Fabricante
Name (English)
PRODUCTOSROCHE, S.A. DE C.V.