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DIINSELDENGUEIGG/IGMRAPIDTEST DEVICE - COFEPRIS Registration 383R2022 SSA

Access comprehensive regulatory information for DIINSELDENGUEIGG/IGMRAPIDTEST DEVICE (DIINSELDENGUEIGG/IGMRAPIDTEST DEVICE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 383R2022 SSA and manufactured by DIINSEL, S.A. DE C.V.. The device was registered on May 17, 2022.

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
383R2022 SSA
DIINSELDENGUEIGG/IGMRAPIDTEST DEVICE
COFEPRIS Analysis ID: 383R2022 SSA
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Product Use / Uso del Producto
Spanish

EL DISPOSITIVO DIINSEL DENGUE IGG/IGM RAPID TESTDEVICE DE PRUEBA RÁPIDA DENGUE IGG/IGM (SANGRETOTAL/SUERO/PLASMA) ES UN INMUNOENSAYOCROMATOGRÁFICO RÁPIDO PARA LA DETECCIÓNCUALITATIVADEANTICUERPOSIGGEIGMCONTRAELVIRUSDE DENGUE EN SANGRE, SUERO O PLASMA HUMANOCOMPLETO COMO AYUDA EN EL DIAGNÓSTICO DE LAENFERMEDADPRIMARIAEINFECCIONESSECUNDARIASPORDENGUE

English

THE DIINSEL DENGUE IGG/IGM RAPID TESTDEVICE RAPID DENGUE IGG/IGM (WHOLE BLOOD/SERUM/PLASMA) RAPID TESTDEVICE IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF SIGGEIGM ANTIBODY AGAINST DENGUE VIRUS IN BLOOD, SERUM OR WHOLE HUMAN PLASMA AS AN AID IN THE DIAGNOSIS OF PRIMARY DISEASE AND SECONDARY INFECTIONS.

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 PARADETECCIÓN DE DENGUE
Trade Name (English)
RAPID TEST FOR DENGUE DETECTION
Registration Information
Analysis ID
383R2022 SSA
Registration Date
May 17, 2022
Manufacturer / Fabricante
Name (Spanish)
DIINSEL, S.A. DE C.V.
Name (English)
DIINSEL, S.A. DE C.V.