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FLUOROCELL PLT, REACTIVO PARA ETIQUETAR LAS PLAQUETAS EN UNA MUESTRA DE SANGRE DILUIDA. - COFEPRIS Registration 1716R2018 SSA

Access comprehensive regulatory information for FLUOROCELL PLT, REACTIVO PARA ETIQUETAR LAS PLAQUETAS EN UNA MUESTRA DE SANGRE DILUIDA. (FLUOROCELL PLT, A REAGENT FOR LABELING PLATELETS IN A DILUTED 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 1716R2018 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on July 12, 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
1716R2018 SSA
FLUOROCELL PLT, REACTIVO PARA ETIQUETAR LAS PLAQUETAS EN UNA MUESTRA DE SANGRE DILUIDA.
COFEPRIS Analysis ID: 1716R2018 SSA
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Product Use / Uso del Producto
Spanish

DEBE USARSE FLUOROCELL PLT PARA ETIQUETAR LAS PLAQUETAS EN UNA MUESTRA DE SANGRE DILUIDA PARA EL ENSAYO DEL RECUENTO DE PLAQUETAS EN LA SANGRE MEDIANTE LOS ANALIZADORES HEMATOLÓGICOS AUTOMATIZADOS DE SYSMEX.

English

FLUOROCELL PLT SHOULD BE USED TO LABEL PLATELETS IN A DILUTED BLOOD SAMPLE FOR BLOOD PLATELET COUNT TESTING USING SYSMEX'S AUTOMATED HEMATOLOGY 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 PARA ETIQUETAR PLAQUETAS.
Trade Name (English)
REAGENT FOR LABELING PLATELETS.
Registration Information
Analysis ID
1716R2018 SSA
Registration Date
July 12, 2018
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.