Pure Global

BIOSYNEX® DENGUE NS1 - COFEPRIS Registration 1883R2018 SSA

Access comprehensive regulatory information for BIOSYNEX® DENGUE NS1 (BIOSYNEX® DENGUE NS1) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1883R2018 SSA and manufactured by PHARMACUR, S.A. DE C.V.. The device was registered on August 03, 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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase II
1883R2018 SSA
BIOSYNEX® DENGUE NS1
COFEPRIS Analysis ID: 1883R2018 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

EL CASETE DE PRUEBA RÁPIDA BIOSYNEX® DENGUE NS1 (SANGRE TOTAL/SUERO/PLASMA) ES UN INMUNOENSAYO CROMATOGRÁFICO RÁPIDO PARA LA DETECCIÓN CUALITATIVA DE ANTÍGENO DENGUE NS1 EN SANGRE, SUERO O PLASMA HUMANOS. AGENTE DE DIAGNÓSTICO IN VITRO PARA USO EXCLUSIV

English

THE BISYNEX® DENGUE NS1 (WHOLE BLOOD/SERUM/PLASMA) RAPID TEST CASSETTE IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF DENGUE NS1 ANTIGEN IN HUMAN BLOOD, SERUM OR PLASMA. IN VITRO DIAGNOSTIC AGENT FOR EXCLUSIVE USE

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 PARA LA DETECCIÓN CUALITATIVA DE DENGUE NS1
Trade Name (English)
RAPID TEST FOR THE QUALITATIVE DETECTION OF DENGUE NS1
Registration Information
Analysis ID
1883R2018 SSA
Registration Date
August 03, 2018
Manufacturer / Fabricante
Name (English)
PHARMACUR, S.A. DE C.V.