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CELL-DYN EMERALD CN-FREELYSE. - COFEPRIS Registration 0793R2022 SSA

Access comprehensive regulatory information for CELL-DYN EMERALD CN-FREELYSE. (CELL-MAN EMERALD CN-FREELYSE.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 0793R2022 SSA and manufactured by ABBOTTLABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on August 16, 2022.

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
0793R2022 SSA
CELL-DYN EMERALD CN-FREELYSE.
COFEPRIS Analysis ID: 0793R2022 SSA
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Product Use / Uso del Producto
Spanish

EL CELL-DYN EMERALD CN-FREE LYSE REALIZA LOSIGUIENTE•HEMOLIZALOSERITROCITOSCONRAPIDEZYMINIMIZAELESTROMACELULARRESULTANTE.•ALTERALAMEMBRANADELOSLEUCOCITOSPARAPERMITIRQUEELCITOPLASMASEDIFUNDAYREDUCELAMEMBRANADELNÚCLEO Y TO

English

THE CELL-DYN EMERALD CN-FREE LYSE PERFORMS THE FOLLOWING•HEMOLYSTALALISALOSERITROCYTES RAPIDLY AND MINIMISES THE RESULTING CELLULAR STROMA.•ALTERS THE MEMBRANE OF THE LEUKOCYTES TO ALLOW THE CYTOPLASM TO DIFFUSE AND SHRINK THE MEMBRANE OF THE NUCLEUS AND TO

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 HEMOLIZANTE
Trade Name (English)
HEMOLIZING REAGENT
Registration Information
Analysis ID
0793R2022 SSA
Registration Date
August 16, 2022
Manufacturer / Fabricante
Name (English)
ABBOTTLABORATORIES DE MÉXICO, S.A. DE C.V.