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ATELLICA TM IM FIBROSIS HEPÁTICA (ELF) - COFEPRIS Registration 67R2019 SSA

Access comprehensive regulatory information for ATELLICA TM IM FIBROSIS HEPÁTICA (ELF) (ATELLICA TM IM FIBROSIS HEPÁTICA (ELF)) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 67R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.. The device was registered on January 25, 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 II
67R2019 SSA
ATELLICA TM IM FIBROSIS HEPÁTICA (ELF)
COFEPRIS Analysis ID: 67R2019 SSA
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Product Use / Uso del Producto
Spanish

LA PRUEBA ATELLICA ™ IM ENHANCED LIVER FIBROSIS (ELF) ES UN ENSAYO DE ÍNDICE MULTIVARIADO DE DIAGNÓSTICO IN VITRO DISEÑADO PARA PROPORCIONAR UNA PUNTUACIÓN ÚNICA DE ELF AL COMBINAR EN UN ALGORITMO LAS MEDICIONES CUANTITATIVAS DE ÁCIDO HIALURÓNICO (HA), PR

English

THE ATELLICA ™ IM ENHANCED LIVER FIBROSIS (ELF) TEST IS A MULTIVARIATE IN VITRO DIAGNOSTIC INDEX ASSAY DESIGNED TO PROVIDE A UNIQUE ELF SCORE BY COMBINING QUANTITATIVE MEASUREMENTS OF HYALURONIC ACID (HA), PR

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)
ENSAYO PARA LA DETERMINACIÓN DE FIBROSIS HEPÁTICA
Trade Name (English)
TEST FOR THE DETERMINATION OF LIVER FIBROSIS
Registration Information
Analysis ID
67R2019 SSA
Registration Date
January 25, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.