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CHORUS DSDNA-M - COFEPRIS Registration 1336R2019 SSA

Access comprehensive regulatory information for CHORUS DSDNA-M (CHORUS DSDNA-M) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1336R2019 SSA and manufactured by GRIFOLS MÉXICO, S.A. DE C.V.. The device was registered on July 16, 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 I
1336R2019 SSA
CHORUS DSDNA-M
COFEPRIS Analysis ID: 1336R2019 SSA
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Product Use / Uso del Producto
Spanish

MÉTODO INMUNOENZIMÁTICO PARA LA DETERMINACIÓN SEMICUANTITATIVA DE ANTICUERPOS IGM ANTI-DSDNA EN SUERO HUMANO CON DISPOSITIVO DESECHABLE APLICADO A LOS EQUIPOS CHORUS Y CHORUS TRIO.

English

IMMUNOENZYMATIC METHOD FOR THE SEMIQUANTITATIVE DETERMINATION OF IGM ANTI-DSDNA ANTIBODIES IN HUMAN SERUM WITH DISPOSABLE DEVICE APPLIED TO CHORUS AND CHORUS TRIO EQUIPMENT.

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)
REACTIVO PARA LA DETERMINACIÓN DE ANTICUERPOS IGM ANTI-DSDNA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF IGM ANTI-DSDNA ANTIBODIES
Registration Information
Analysis ID
1336R2019 SSA
Registration Date
July 16, 2019
Manufacturer / Fabricante
Name (English)
GRIFOLS MÉXICO, S.A. DE C.V.