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REACTIVO DEINMUNOFLUORESCENCIA DIRECTAPARA LA IDENTIFICACIÓN YENUMERACIÓN DE CÉLULAS QUEEXPRESAN - COFEPRIS Registration 1830R2021 SSA

Access comprehensive regulatory information for REACTIVO DEINMUNOFLUORESCENCIA DIRECTAPARA LA IDENTIFICACIÓN YENUMERACIÓN DE CÉLULAS QUEEXPRESAN (DIRECT IMMUNOFLUORESCENCE REAGENT FOR THE IDENTIFICATION AND ENUMERATION OF CELLS EXPRESSING) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1830R2021 SSA and manufactured by DICIPA, S.A. DE C.V.. The device was registered on November 11, 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 I
1830R2021 SSA
REACTIVO DEINMUNOFLUORESCENCIA DIRECTAPARA LA IDENTIFICACIÓN YENUMERACIÓN DE CÉLULAS QUEEXPRESAN
COFEPRIS Analysis ID: 1830R2021 SSA
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Product Use / Uso del Producto
Spanish

EL CYCD79A-PE (CLON: HM57) ES UNANTICUERPO MONOCLONAL (ACMO)CONJUGADO CON R- FICOERITRINA (PE)DISEÑADO PARA SU UTILIZACIÓN PORCITOMETRÍADEFLUJO(CF)COMOREACTIVODEINMUNOFLUORESCENCIADIRECTAENLAIDENTIFICACIÓN Y ENUMERACIÓN DECÉLULAS QUE EXPRESAN EL ANTÍGENOCD79Α. AGENTEDEDIAGNÓSTICOPARAUSO IN VITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLÍNICOS O DE GABINETES

English

CYCD79A-PE (CLONE: HM57) IS A R-PHYCOERYTHRIN-CONJUGATED MONOCLONAL ANTIBODY (CCA) DESIGNED FOR USE BY FLOW CYTOMETRY (CF) AS A DIRECT IMMUNOFLUORESCENCE REAGENT IN THE IDENTIFICATION AND ENUMERATION OF CELLS EXPRESSING ANTIGEN CD79A. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL LABORATORIES OR CABINETS ONLY

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
CYCD79A-PE
Trade Name (English)
CYCD79A-PE
Registration Information
Analysis ID
1830R2021 SSA
Registration Date
November 11, 2021
Manufacturer / Fabricante
Name (Spanish)
DICIPA, S.A. DE C.V.
Name (English)
DICIPA, S.A. DE C.V.