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STROMATOLYSER™-4D REACTIVO PARA CLASIFICAR LEUCOCITOS. - COFEPRIS Registration 2236R2019 SSA

Access comprehensive regulatory information for STROMATOLYSER™-4D REACTIVO PARA CLASIFICAR LEUCOCITOS. (STROMATOLYSER-4D™ REAGENT FOR CLASSIFYING LEUKOCYTES.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2236R2019 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on December 10, 2019.

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
2236R2019 SSA
STROMATOLYSER™-4D REACTIVO PARA CLASIFICAR LEUCOCITOS.
COFEPRIS Analysis ID: 2236R2019 SSA
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Product Use / Uso del Producto
Spanish

STROMATOLYSER™ -4D REACTIVO PARA CLASIFICAR LEUCOCITOS. ES UN REACTIVO QUE SE UTILIZA EN COMBINACIÓN CON LA SOLUCIÓN DE TINCIÓN ESPECÍFICA (STROMATOLYSER™ -4DS), PARA CLASIFICAR LOS LEUCOCITOS MEDIANTE EL MÉTODO DE CITOMETRÍA DE FLUJO CON LÁSER SEMICONDUC

English

STROMATOLYSER™ -4D REAGENT FOR CLASSIFYING LEUKOCYTES. IT IS A REAGENT THAT IS USED IN COMBINATION WITH THE SPECIFIC STAINING SOLUTION (STROMATOLYSER™ -4DS), TO CLASSIFY LEUKOCYTES BY THE SEMICONDUCTOR LASER FLOW CYTOMETRY METHOD

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 CLASIFICAR LEUCOCITOS.
Trade Name (English)
REAGENT FOR CLASSIFYING LEUKOCYTES.
Registration Information
Analysis ID
2236R2019 SSA
Registration Date
December 10, 2019
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.