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LH LYSE - COFEPRIS Registration 1438R2018 SSA

Access comprehensive regulatory information for LH LYSE (LH LYSE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1438R2018 SSA and manufactured by ATYDE MÉXICO, S.A. DE C.V.. The device was registered on June 07, 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 II
1438R2018 SSA
LH LYSE
COFEPRIS Analysis ID: 1438R2018 SSA
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Product Use / Uso del Producto
Spanish

ESTE PRODUCTO ES UTILIZADO PARA LISAR GLÓBULOS ROJOS Y MANTENER LA MORFOLOGÍA CELULAR NECESARIA PARA ANALIZAR LAS CÉLULAS SANGUÍNEAS Y DETERMINAR LA HEMOGLOBINA. PARA USO EXCLUSIVO EN LABORATORIOS CLÍNICOS Y GABINETES.

English

THIS PRODUCT IS USED TO LYSE RED BLOOD CELLS AND MAINTAIN THE CELL MORPHOLOGY NEEDED TO ANALYZE BLOOD CELLS AND DETERMINE HEMOGLOBIN. FOR EXCLUSIVE USE IN CLINICAL LABORATORIES AND CABINETS.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
SOLUCIÓN DE LISIS DE GLÓBULOS ROJOS
Trade Name (English)
RED BLOOD CELL LYSIS SOLUTION
Registration Information
Analysis ID
1438R2018 SSA
Registration Date
June 07, 2018
Manufacturer / Fabricante
Name (English)
ATYDE MÉXICO, S.A. DE C.V.