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DIAQUICK DENGUE NS1 AG CASSETTE - COFEPRIS Registration 1680R2018 SSA

Access comprehensive regulatory information for DIAQUICK DENGUE NS1 AG CASSETTE (DIAQUICK DENGUE NS1 AG CASSETTE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1680R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on July 04, 2018.

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 II
1680R2018 SSA
DIAQUICK DENGUE NS1 AG CASSETTE
COFEPRIS Analysis ID: 1680R2018 SSA
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Product Use / Uso del Producto
Spanish

EL DIAQUICK DENGUE NS1 AG CASSETTE, ES UN DISPOSITIVO DE FLUJO LATERAL INMUNOCROMATOGRÁFICO, BASADO EN MEMBRANA, PARA LA DETECCIÓN CUALITATIVA DEL ANTÍGENO NS1 DEL DENGUE EN PLASMA, SUERO Y SANGUE TOTAL HUMANA. EL TEST UTILIZA ANTICUERPOS MONOCLONALES ESP

English

THE DIAQUICK DENGUE NS1 AG CASSETTE IS A MEMBRANE-BASED, IMMUNOCHROMATOGRAPHIC LATERAL FLOW DEVICE FOR THE QUALITATIVE DETECTION OF DENGUE NS1 ANTIGEN IN PLASMA, SERUM AND HUMAN TOTAL BLOOD. THE TEST USES ESP MONOCLONAL ANTIBODIES

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RÁPIDA INMUNOCROMATOGRÁFICA DE FLUJO LATERAL PARA LA DETECCIÓN CUALITATIVA DEL ANTÍGENO NS1 D
Trade Name (English)
RAPID LATERAL FLOW IMMUNOCHROMATOGRAPHIC TEST FOR QUALITATIVE DETECTION OF NS1 D ANTIGEN
Registration Information
Analysis ID
1680R2018 SSA
Registration Date
July 04, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.