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ATELLICA TM IM CA 19-9 - COFEPRIS Registration 1329R2018 SSA

Access comprehensive regulatory information for ATELLICA TM IM CA 19-9 (ATELLICA TM IM CA 19-9) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1329R2018 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 II
1329R2018 SSA
ATELLICA TM IM CA 19-9
COFEPRIS Analysis ID: 1329R2018 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ATELLICA™ IM CA 19-9 ESTÁ PREVISTO PARA USO DIAGNÓSTICO IN VITRO PARA LA DETERMINACIÓN CUANTITATIVA EN SERIE DE CA 19-9 EN SUERO HUMANO. EL ATELLICA™ IM CA 19-9 DIL ES UN DILUYENTE PARA USO DIAGNÓSTICO IN VITRO. AGENTE DE DIAGNÓSTICO. PARA USO

English

THE ATELLICA™ IM CA 19-9 ASSAY IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE SERIAL QUANTITATIVE DETERMINATION OF CA 19-9 IN HUMAN SERUM. ATELLICA™ IM CA 19-9 DIL IS A DILUENT FOR IN VITRO DIAGNOSTIC USE. DIAGNOSTIC AGENT. FOR 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)
ENSAYO PARA LA DETERMINACIÓN DE CA 19-9
Trade Name (English)
TEST FOR THE DETERMINATION OF CA 19-9
Registration Information
Analysis ID
1329R2018 SSA
Registration Date
June 04, 2018
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.