Mexico COFEPRIS registration 438R2021 SSA

CELQUANT 360 REAGENTS

EN: CELQUANT 360 REAGENTS
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·ISA HEALTH S.A. DE C.V.·Registered March 17, 2021
Product Use / Uso del Producto
Spanish

LOSREACTIVOSCELQUANT360SONUSADOSPOR EL ANALIZADOR HEMATOLÓGICOCELQUANT 360 EN CONJUNTO, PARA LAMEDICIÓN DE DIVERSOS PARÁMETROSHEMATOLÓGICOS (CONTEO DE GLÓBULOSROJOS, TROMBOCITOS, HEMOGLOBINA,GLÓBULOS BLANCOS, LINFOCITOS,MONOCITOS Y GRANULOCITOS).

English

CELQUANT360 REAGENTS ARE USED BY THE CELQUANT 360 HAEMATOLOGICAL ANALYSER TOGETHER, FOR THE MEASUREMENT OF VARIOUS HAEMATOLOGICAL PARAMETERS (RED BLOOD CELL COUNT, THROMBOCYTES, HAEMOGLOBIN, WHITE BLOOD CELLS, LYMPHOCYTES, MONOCYTES AND GRANULOCYTES).

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)
REACTIVOS PARA ANALISIS HEMATOLOGICO
Trade Name (English)
REAGENTS FOR HEMATOLOGICAL ANALYSIS
Registration information
Analysis ID
438R2021 SSA
Registration Date
March 17, 2021
Manufacturer / Fabricante
Name (English)
ISA HEALTH S.A. DE C.V.
About this record

Access comprehensive regulatory information for CELQUANT 360 REAGENTS (CELQUANT 360 REAGENTS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 438R2021 SSA and manufactured by ISA HEALTH S.A. DE C.V.. The device was registered on March 17, 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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