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COBAS® HIV-1/HIV-2 QUALITATIVE - COFEPRIS Registration 545R2021 SSA

Access comprehensive regulatory information for COBAS® HIV-1/HIV-2 QUALITATIVE (COBAS® HIV-1/HIV-2 QUALITATIVE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 545R2021 SSA and manufactured by PRODUCTOS ROCHE,S.A. DE C.V.. The device was registered on March 29, 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.

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COFEPRIS Official Data
Clase II
545R2021 SSA
COBAS® HIV-1/HIV-2 QUALITATIVE
COFEPRIS Analysis ID: 545R2021 SSA
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Product Use / Uso del Producto
Spanish

PRUEBA DE AMPLIFICACIÓN DE ÁCIDOSNUCLEICOS PARA LA DETECCIÓNCUALITATIVA Y DIFERENCIACIÓN DEL VIRUSDEINMUNODEFICIENCIAHUMANO(VIH)TIPO1 (VIH-1) Y TIPO 2 (VIH-2).

English

NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION AND DIFFERENTIATION OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) TYPE 1 (HIV-1) AND TYPE 2 (HIV-2).

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)
PRUEBA DE AMPLIFICACIÓN DE ÁCIDOSNUCLEICOS PARA LA DETECCIÓNCUALITATIVA Y DIFERENCIACIÓN DEL VIRUS
Trade Name (English)
NUCLEIC ACID AMPLIFICATION TEST FOR QUALITATIVE DETECTION AND DIFFERENTIATION OF THE VIRUS
Registration Information
Analysis ID
545R2021 SSA
Registration Date
March 29, 2021
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE,S.A. DE C.V.