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QUANTA FLASH® CALPROTECTIN CONTROLS - COFEPRIS Registration 1048R2019 SSA

Access comprehensive regulatory information for QUANTA FLASH® CALPROTECTIN CONTROLS (QUANTA FLASH® CALPROTECTIN CONTROLS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1048R2019 SSA and manufactured by I.L. DIAGNOSTICS, S.A. DE C.V.. The device was registered on May 17, 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
1048R2019 SSA
QUANTA FLASH® CALPROTECTIN CONTROLS
COFEPRIS Analysis ID: 1048R2019 SSA
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Product Use / Uso del Producto
Spanish

LOS QUANTA FLASH CALPROTECTIN CONTROLS ESTÁN DESTINADOS A UTILIZARSE CON LOS REACTIVOS QUANTA FLASH CALPROTECTIN REAGENTS PARA EL CONTROL DE CALIDAD EN LA DETERMINACIÓN DE LOS NIVELES DE CALPROTECTINA FECAL EN MUESTRAS DE HECES EXTRAÍDAS. AGENTE DE DIAG

English

QUANTA FLASH CALPROTECTIN CONTROLS ARE INTENDED FOR USE WITH QUANTA FLASH CALPROTECTIN REAGENTS FOR QUALITY CONTROL IN DETERMINING FECAL CALPROTECTIN LEVELS IN COLLECTED STOOL SAMPLES. DIAG AGENT

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)
CONTROLES PARA INMUNOENSAYO POR QUIMIOLUMINISCENCIA
Trade Name (English)
CONTROLS FOR CHEMILUMINESCENCE IMMUNOASSAY
Registration Information
Analysis ID
1048R2019 SSA
Registration Date
May 17, 2019
Manufacturer / Fabricante
Name (English)
I.L. DIAGNOSTICS, S.A. DE C.V.