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FLUOROCELL WDF, REACTIVO PARA DETERMINACIÓN DEL DIFERENCIAL WBC. - COFEPRIS Registration 1817R2018 SSA

Access comprehensive regulatory information for FLUOROCELL WDF, REACTIVO PARA DETERMINACIÓN DEL DIFERENCIAL WBC. (FLUOROCELL WDF, REAGENT FOR DETERMINATION OF THE WBC DIFFERENTIAL.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1817R2018 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on July 26, 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
1817R2018 SSA
FLUOROCELL WDF, REACTIVO PARA DETERMINACIÓN DEL DIFERENCIAL WBC.
COFEPRIS Analysis ID: 1817R2018 SSA
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Product Use / Uso del Producto
Spanish

DEBE USARSE FLUOROCELL WDF PARA ETIQUETAR LOS LEUCOCITOS EN UNA MUESTRA DE SANGRE DILUIDA Y HEMOLIZADA PARA LA DETERMINACIÓN DEL DIFERENCIAL DE WBC MEDIANTE LOS ANALIZADORES HEMATOLÓGICOS AUTOMATIZADOS DE SYSMEX.

English

FLUOROCELL WDF SHOULD BE USED TO LABEL LEUKOCYTES IN A DILUTED AND HEMOLYZED BLOOD SAMPLE FOR DETERMINATION OF WBC DIFFERENTIAL USING SYSMEX AUTOMATED HEMATOLOGIC ANALYZERS.

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 HEMATOLOGY ANALYZERS
Registration Information
Analysis ID
1817R2018 SSA
Registration Date
July 26, 2018
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.