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ATELLICA™ IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN - COFEPRIS Registration 506R2019 SSA

Access comprehensive regulatory information for ATELLICA™ IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (ATELLICA™ IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 506R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.. The device was registered on March 12, 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
506R2019 SSA
ATELLICA™ IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN
COFEPRIS Analysis ID: 506R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ATELLICA™ IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (ATELLICA™ IM CPSA) ESTÁ PREVISTO PARA USO DIAGNÓSTICO IN VITRO EN LA DETERMINACIÓN CUANTITATIVA DE ANTÍGENO PROSTÁTICO ESPECÍFICO UNIDO (CPSA) EN SUERO HUMANO.

English

THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN ASSAY (ATELLICA™™ IM CPSA) IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF BOUND PROSTATE-SPECIFIC ANTIGEN (CPSA) IN HUMAN SERUM.

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 ANTÍGENO PROSTÁTICO ESPECÍFICO UNIDO (CPSA)
Trade Name (English)
PROSTATE-SPECIFIC BOUND ANTIGEN (PSC) ASSAY
Registration Information
Analysis ID
506R2019 SSA
Registration Date
March 12, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L DE C.V.