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QUANTA FLASH® CALPROTECTIN REAGENTS - COFEPRIS Registration 1049R2019 SSA

Access comprehensive regulatory information for QUANTA FLASH® CALPROTECTIN REAGENTS (QUANTA FLASH® CALPROTECTIN 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 1049R2019 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
1049R2019 SSA
QUANTA FLASH® CALPROTECTIN REAGENTS
COFEPRIS Analysis ID: 1049R2019 SSA
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Product Use / Uso del Producto
Spanish

EL QUANTA FLASH CALPROTECTIN ES UN INMUNOENSAYO POR QUIMIOLUMINISCENCIA PARA LA DETERMINACIÓN CUANTITATIVA DE CALPROTECTINA FECAL EN MUESTRAS DE HECES HUMANAS EXTRAÍDAS. UNOS NIVELES ELEVADOS DE CALPROTECTINA FECAL, JUNTO CON LOS RESULTADOS CLÍNICOS Y OTR

English

QUANTA FLASH CALPROTECTIN IS A CHEMILUMINESCENCE IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF FECAL CALPROTECTIN IN COLLECTED HUMAN STOOL SAMPLES. ELEVATED FECAL CALPROTECTIN LEVELS, ALONG WITH CLINICAL AND OTHER OUTCOMES

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)
INMUNOENSAYO QUIMIOLUMINISCENTE AUTOMÁTICO PARA LA DETERMINACIÓN DE CALPROTECTINA FECAL
Trade Name (English)
AUTOMATIC CHEMILUMINESCENT IMMUNOASSAY FOR THE DETERMINATION OF FECAL CALPROTECTIN
Registration Information
Analysis ID
1049R2019 SSA
Registration Date
May 17, 2019
Manufacturer / Fabricante
Name (English)
I.L. DIAGNOSTICS, S.A. DE C.V.