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FLUOROCELL RET, REACTIVO PARA ETIQUETAR LOS RETICULOCITOS EN UNA MUESTRA DE SANGRE DILUIDA - COFEPRIS Registration 1717R2018 SSA

Access comprehensive regulatory information for FLUOROCELL RET, REACTIVO PARA ETIQUETAR LOS RETICULOCITOS EN UNA MUESTRA DE SANGRE DILUIDA (FLUOROCELL RET, REAGENT FOR LABELING RETICULOCYTES 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 1717R2018 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
1717R2018 SSA
FLUOROCELL RET, REACTIVO PARA ETIQUETAR LOS RETICULOCITOS EN UNA MUESTRA DE SANGRE DILUIDA
COFEPRIS Analysis ID: 1717R2018 SSA
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Product Use / Uso del Producto
Spanish

DEBE USARSE FLUOROCELL RET PARA ETIQUETAR LOS RETICULOCITOS EN UNA MUESTRA DE SANGRE DILUIDA PARA EL ENSAYO DEL RECUENTO DE RETICULOCITOS, PORCENTAJE DE RETICULOCITOS Y RECUENTO DE PLAQUETAS EN LA SANGRE MEDIANTE LOS ANALIZADORES HEMATOLÓGICOS AUTOMATIZAD

English

FLUOROCELL RET SHOULD BE USED TO LABEL RETICULOCYTES IN A DILUTED BLOOD SAMPLE FOR THE RETICULOCYTE COUNT, RETICULOCYTE PERCENTAGE, AND BLOOD PLATELET COUNT ASSAY USING 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 RETICULOCITOS
Trade Name (English)
REAGENT FOR LABELING RETICULOCYTES
Registration Information
Analysis ID
1717R2018 SSA
Registration Date
July 12, 2018
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.