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REACTIVOS Y CONTROLES DEHEMATOLOGÍA ELITE - COFEPRIS Registration 648R2021 SSA

Access comprehensive regulatory information for REACTIVOS Y CONTROLES DEHEMATOLOGÍA ELITE (REAGENTS AND CONTROLS DEHEMATOLOGY ELITE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 648R2021 SSA and manufactured by HRD HIGHRESOLUTION DIAGNOSTICS, S.A. DEC.V.. The device was registered on April 15, 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
648R2021 SSA
REACTIVOS Y CONTROLES DEHEMATOLOGÍA ELITE
COFEPRIS Analysis ID: 648R2021 SSA
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Product Use / Uso del Producto
Spanish

ELREACTIVOELITEH580DILSEUTILIZAPARADILUIR SANGRE Y PROPORCIONAR UNENTORNO ESTABLE PARA CONTAR YDETERMINAR EL TAMAÑO DE LAS CÉLULASSANGUÍNEAS, LOS REACTIVOS ELITE H580LYSE1,ELITEH580LYSE2YELITEH580LYSE3SEUSANPARALISARLOSGLÓBULOSROJOSPARA EL RECUENTO DE HEMOGLOBINA YGLÓBULOS BLANCOS, Y PARA LADIFERENCIACIÓN DE GLÓBULOS BLANCOS.MIENTRAS QUE LOS CONTROLES ELITE H5CONESTÁNDESTINADOSPARAEVALUARLAPRECISIÓN Y EXACTITUD DE LOSANALIZADORES DE HEMATOLOGÍA. LOS

English

THE ELITEH580DIL REAGENT IS USED TO DILUTE BLOOD AND PROVIDE A STABLE ENVIRONMENT FOR COUNTING AND DETERMINING THE SIZE OF BLOOD CELLS, THE ELITE REAGENTS H580LYSE1,ELITEH580LYSE2AND ELITEH580LYSE3SEUSANPARALYSTHERED BLOOD CELLS FOR HAEMOGLOBIN AND WHITE BLOOD CELL COUNTS, AND FOR WHITE BLOOD CELL DIFFERENTIATION. WHILE ELITE H5 CONTROLS ARE INTENDED TO EVALUATE THE PRECISION AND ACCURACY OF HAEMATOLOGY ANALYSERS. THE

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)
KIT DE DIAGNÓSTICO IN VITRO PARAHEMATOLOGÍA
Trade Name (English)
IN VITRO DIAGNOSTIC KIT FOR HEMATOLOGY
Registration Information
Analysis ID
648R2021 SSA
Registration Date
April 15, 2021
Manufacturer / Fabricante
Name (English)
HRD HIGHRESOLUTION DIAGNOSTICS, S.A. DEC.V.