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SOX-11 (MRQ-58) MOUSEMONOCLONAL PRIMARYANTIBODY - COFEPRIS Registration 322R2020 SSA

Access comprehensive regulatory information for SOX-11 (MRQ-58) MOUSEMONOCLONAL PRIMARYANTIBODY (SOX-11 (MRQ-58) MOUSEMONOCLONAL PRIMARYANTIBODY) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 322R2020 SSA and manufactured by PRODUCTOS ROCHE, S.A. DEC.V.. The device was registered on March 13, 2020.

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
322R2020 SSA
SOX-11 (MRQ-58) MOUSEMONOCLONAL PRIMARYANTIBODY
COFEPRIS Analysis ID: 322R2020 SSA
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Product Use / Uso del Producto
Spanish

EL ANTICUERPO PRIMARIO MONOCLONAL DERATÓNSOX-11(MRQ-58)ESTÁDISEÑADOPARADETECTAR LA PROTEÍNA SOX-11 EN TEJIDOSEMBEBIDOS EN PARAFINA, FIJADOS CONFORMALINA Y TEÑIDOS EN PRUEBAS DEINMUNOHISTOQUÍMICA (IHC) CUALITATIVA.PARA LA IDENTIFICACIÓN Y DIFERENCIACIÓN DE LOSLINFOMASDECÉLULASDEMANTODENTRODELCONTEXTODEUNPANELDEANTICUERPOS.AGENTEDEDIAGNÓSTICOPARAUSOINVITRO.PARA USO EXCLUSIVO EN LABORATORIOSCLÍNICOS O DE GABINETES.

English

THE MONOCLONAL MONOCLONAL ANTIBODY SOX-11(MRQ-58) IS DESIGNED TO DETECT THE SOX-11 PROTEIN IN PARAFFIN-EMBED, CONFORMALINE-FIXED, AND STAINED TISSUES IN QUALITATIVE IMMUNOHISTOCHEMISTRY (IHC) TESTS. FOR THE IDENTIFICATION AND DIFFERENTIATION OF LYMPHOMASFROMCELLS WITHIN THE CONTEXT OF AN ANTIBODY PANEL. DIAGNOSTICAGENTFORUSEINVITRO. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

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)
ANTICUERPO MONOCLONAL
Trade Name (English)
MONOCLONAL ANTIBODY
Registration Information
Analysis ID
322R2020 SSA
Registration Date
March 13, 2020
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DEC.V.