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FLUOROCELL WNR, REACTIVO PARA ETIQUETAR LAS CÉLULAS NUCLEADAS EN UNA MUESTRA DE SANGRE. - COFEPRIS Registration 1807R2018 SSA

Access comprehensive regulatory information for FLUOROCELL WNR, REACTIVO PARA ETIQUETAR LAS CÉLULAS NUCLEADAS EN UNA MUESTRA DE SANGRE. (FLUOROCELL WNR, A REAGENT FOR LABELING NUCLEATED CELLS IN A BLOOD SAMPLE.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1807R2018 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on July 25, 2018.

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
1807R2018 SSA
FLUOROCELL WNR, REACTIVO PARA ETIQUETAR LAS CÉLULAS NUCLEADAS EN UNA MUESTRA DE SANGRE.
COFEPRIS Analysis ID: 1807R2018 SSA
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DJ Fang

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Product Use / Uso del Producto
Spanish

DEBE USARSE FLUOROCELL WNR PARA ETIQUETAR LAS CÉLULAS NUCLEADAS EN UNA MUESTRA DE SANGRE DILUIDA Y HEMOLIZADA PARA LA DETERMINACIÓN DEL RECUENTO DE LEUCOCITOS, EL RECUENTO DE HEMATÍES NUCLEADOS Y EL RECUENTO DE BASÓFILOS EN LA SANGRE MEDIANTE LOS ANALIZAD

English

FLUOROCELL WNR SHOULD BE USED TO LABEL NUCLEATED CELLS IN A DILUTED AND HEMOLYZED BLOOD SAMPLE FOR DETERMINATION OF WHITE BLOOD CELL COUNT, NUCLEATED RED BLOOD CELL COUNT, AND BASOPHILIC COUNT IN THE BLOOD BY

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)
REACTIVO COLORANTE PARA ANALIZADORES HEMATOLÓGICOS.
Trade Name (English)
DYE REAGENT FOR HEMATOLOGICAL ANALYZERS.
Registration Information
Analysis ID
1807R2018 SSA
Registration Date
July 25, 2018
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.