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COULTER® LH SERIES PAK REAGENT KIT - COFEPRIS Registration 1911R2019 SSA

Access comprehensive regulatory information for COULTER® LH SERIES PAK REAGENT KIT (COULTER® LH SERIES PAK REAGENT KIT) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1911R2019 SSA and manufactured by BECKMAN COULTER DE MÉXICO, S.A. DE C.V.. The device was registered on September 26, 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
1911R2019 SSA
COULTER® LH SERIES PAK REAGENT KIT
COFEPRIS Analysis ID: 1911R2019 SSA
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Product Use / Uso del Producto
Spanish

REACTIVO PARA LISAR ERITROCITOS Y CONSERVAR LEUCOCITOS. PARA SU USO EN LOS ANALIZADORES HEMATOLÓGICOS COULTER HMX, LH 500, LH 750 Y LH 780. UTILICE SÓLO EL DILUYENTE SERIE LH O ISOTON 4. CONSULTE EL MANUAL DE SU INSTRUMENTO O LA AYUDA EN LÍNEA, SEGÚN CORR

English

REAGENT TO LYSE ERYTHROCYTES AND PRESERVE LEUKOCYTES. FOR USE IN COULTER HMX, LH 500, LH 750 AND LH 780 HEMATOLOGY ANALYZERS. USE ONLY THE LH SERIES DILUENT OR ISOTON 4. REFER TO YOUR INSTRUMENT MANUAL OR ONLINE HELP, DEPENDING ON CORR

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 LISIS DE ERITROCITOS Y CONSERVACIÓN DE LEUCOCITOS
Trade Name (English)
REAGENT FOR ERYTHROCYTE LYSIS AND LEUKOCYTE PRESERVATION
Registration Information
Analysis ID
1911R2019 SSA
Registration Date
September 26, 2019
Manufacturer / Fabricante
Name (English)
BECKMAN COULTER DE MÉXICO, S.A. DE C.V.