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ATELLICA TM IM HOMOCYSTEINE - COFEPRIS Registration 1330R2018 SSA

Access comprehensive regulatory information for ATELLICA TM IM HOMOCYSTEINE (ATELLICA TM IM HOMOCYSTEINE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1330R2018 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.. The device was registered on June 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 I
1330R2018 SSA
ATELLICA TM IM HOMOCYSTEINE
COFEPRIS Analysis ID: 1330R2018 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ATELLICA™ IM HOMOCYSTEINE (HCY) ESTÁ PREVISTO PARA USO DIAGNÓSTICO IN VITRO PARA LA DETERMINACIÓN CUANTITATIVA DE HOMOCISTEÍNA TOTAL EN SUERO Y PLASMA (EDTA Y HEPARINA DE LITIO) HUMANOS. EL ATELLICA™ IM HOMOCYSTEINE CALIBRATOR (HCY CAL) ESTÁ PR

English

THE ATELLICA™ IM HOMOCYSTEINE (HCY) ASSAY IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE QUANTITATIVE DETERMINATION OF TOTAL HOMOCYSTEINE IN HUMAN SERUM AND PLASMA (EDTA AND LITHIUM HEPARIN). THE ATELLICA™ IM HOMOCYSTEINE CALIBRATOR (HCY CAL) IS READY

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 DETERMINACIÓN DE HOMOCISTEÍNA
Trade Name (English)
HOMOCYSTEINE ASSAY
Registration Information
Analysis ID
1330R2018 SSA
Registration Date
June 04, 2018
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.