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PRUEBARÁPIDAPARADETECCIÓNDE ANTÍGENO PROSTÁTICO ENSANGRE - COFEPRIS Registration 1108R2021 SSA

Access comprehensive regulatory information for PRUEBARÁPIDAPARADETECCIÓNDE ANTÍGENO PROSTÁTICO ENSANGRE (RAPID TESTFOR DETECTION OF PROSTATIC ANTIGEN IN BLOOD) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1108R2021 SSA and manufactured by DIINSEL, S.A. DE C.V.. The device was registered on December 07, 2021.

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
1108R2021 SSA
PRUEBARÁPIDAPARADETECCIÓNDE ANTÍGENO PROSTÁTICO ENSANGRE
COFEPRIS Analysis ID: 1108R2021 SSA
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Product Use / Uso del Producto
Spanish

ELDIINSELPROSTATESPECIFICANTIGENPSARAPIDTESTDEVICE,ESUNINMUNOENSAYOVISUAL RÁPIDO PARA LA DETECCIÓNCUALITATIVA PRESUNTIVA DE ANTÍGENOSESPECÍFICOSDEPRÓSTATAENMUESTRASDESANGREENTERA,SUEROOPLASMAHUMANO.ESTEKIT ESTÁDISEÑADO PARAUTILIZARSECOMOUNAAYUDAENELDIAGNÓSTICODECÁNCER DE PRÓSTATA.

English

ELDIINSELPROSTATESPECIFICANTIGENPSARAPIDTESTDEVICE IS A RAPID VISUAL IMMUNOASSAY FOR THE PRESUMPTIVE QUALITATIVE DETECTION OF PROSTATE-SPECIFIC ANTIGENS IN SAMPLES OF WHOLE BLOOD, HUMAN SERUM OR HUMAN SEROPLASM. THIS KIT IS DESIGNED TO BE USED AS AN AID IN THE DIAGNOSIS OF PROSTATE CANCER.

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)
DIINSELPROSTATESPECIFICANTIGENPSARAPID TEST DEVICE
Trade Name (English)
DIINSELPROSTATESPECIFICANTIGENPSARAPID TEST DEVICE
Registration Information
Analysis ID
1108R2021 SSA
Registration Date
December 07, 2021
Manufacturer / Fabricante
Name (Spanish)
DIINSEL, S.A. DE C.V.
Name (English)
DIINSEL, S.A. DE C.V.