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ELECSYS TOTAL PSA - COFEPRIS Registration 84R2022 SSA

Access comprehensive regulatory information for ELECSYS TOTAL PSA (ELECSYS TOTAL PSA) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 84R2022 SSA and manufactured by PRODUCTOSROCHE, S.A. DE C.V.. The device was registered on February 08, 2022.

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
84R2022 SSA
ELECSYS TOTAL PSA
COFEPRIS Analysis ID: 84R2022 SSA
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Product Use / Uso del Producto
Spanish

PRUEBAPARALADETECCIÓNCUANTITATIVAINVITRODELANTÍGENO PROSTÁTICO ESPECÍFICO TOTAL (LIBRE YCOMPLEJADO)(TPSA)ENSUEROYPLASMAHUMANOSENLOSANALIZADORESROCHE.JUNTOCONELTACTORECTAL(TR), CONSTITUYE UNA AYUDA EN LA DETECCIÓN DELCÁNCERDEPRÓSTATAENLOSHOMBRESAPARTIRDELOS50AÑOSDEEDAD.ESTAPRUEBASEAPLICAADEMÁSENMEDICIONESSERIADASDELPSATOTALCOMOAYUDAENELMANEJO DE PACIENTES CON CÁNCER. AGENTE DEDIAGNÓSTICOPARAUSOINVITRO.PARAUSOEXCLUSIVOENLABORATORIOS

English

TEST FOR QUANTITATIVE DETECTIONINVITRODELANTIGEN PROSTATE-SPECIFIC TOTAL (FREE AND COMPLEXED)(TPSA) IN HUMAN PLASMAPLASMA IN ROCHE ANALYZERS. TOGETHER WITH THE ECTAL ACTOR(RT), IT IS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN OVER 50 YEARS OF AGE. THIS TEST IS ALSO APPLIED IN SERIAL MEASUREMENTS OF THE TOTAL PSA AS AN AID IN THE MANAGEMENT OF CANCER PATIENTS. DIAGNOSTIC AGENTFORUSEINVITRO. FOR exclusive use in laboratories

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)
PRUEBA PARALA DETECCIÓNDEL ANTÍGENO PROSTÁTICOESPECÍFICO TOTAL (LIBRE YCOMPLEJADO) (TPSA)
Trade Name (English)
TOTAL (FREE AND COMPLEXED) PROSTATE-SPECIFIC ANTIGEN (TPSA) TEST
Registration Information
Analysis ID
84R2022 SSA
Registration Date
February 08, 2022
Manufacturer / Fabricante
Name (English)
PRODUCTOSROCHE, S.A. DE C.V.