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ARCHITECT NSE - COFEPRIS Registration 1982R2021 SSA

Access comprehensive regulatory information for ARCHITECT NSE (ARCHITECT NSE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1982R2021 SSA and manufactured by ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on November 25, 2021.

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
1982R2021 SSA
ARCHITECT NSE
COFEPRIS Analysis ID: 1982R2021 SSA
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Product Use / Uso del Producto
Spanish

ARCHITECT NSE REAGENT KIT. EL ENSAYONSE ES UN INMUNOANÁLISISQUIMIOLUMINISCENTEDEMICROPARTÍCULAS(CMIA)UTILIZADOPARALADETERMINACIÓNCUANTITATIVA DE ENOLASA ESPECIFICA DENEURONA (NSE) EN SUERO HUMANO ENARCHITECT I SYSTEM

English

ARCHITECT NSE REAGENT KIT. THE ASSAY IS A CHEMILUMINESCENT IMMUNOASSAY OF MICROPARTICLES (CMIA) USED FOR THE QUANTITATIVE DETERMINATION OF NEURON-SPECIFIC ENOLASE (NSE) IN HUMAN SERUM IN ARCHITECT I SYSTEM

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)
ENSAYO PARA LA DETERMINACIÓNCUANTITATIVADEENOLASAESPECÍFICADENEURONA (NSE)
Trade Name (English)
ASSAY FOR THE QUANTITATIVE DETERMINATION OF NEURON-SPECIFIC ENOLASE (NSE)
Registration Information
Analysis ID
1982R2021 SSA
Registration Date
November 25, 2021
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.