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EUROLINE ANTI-MPO, -PR3 (IGG) - COFEPRIS Registration 704R2022 SSA

Access comprehensive regulatory information for EUROLINE ANTI-MPO, -PR3 (IGG) (EUROLINE ANTI-MPO, -PR3 (IGG)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 704R2022 SSA and manufactured by INOCHEM S.A. DE C.V.. The device was registered on July 29, 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
704R2022 SSA
EUROLINE ANTI-MPO, -PR3 (IGG)
COFEPRIS Analysis ID: 704R2022 SSA
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Product Use / Uso del Producto
Spanish

ELENSAYOEUROLINESIRVEPARALADETERMINACIÓNINVITRO CUALITATIVA DE ANTICUERPOS HUMANOS DE LACLASE DE INMUNOGLOBULINA IGG CONTRA LOS 2ANTÍGENOS: MIELOPEROXIDASA (MPO) Y PROTEINASA 3(PR3)ENSUEROOPLASMAPARAELDIAGNÓSTICODELAGRANULOMATOSISCONPOLIANGITIS(DEWEGENER)(GPA)YLAARTERITISMICROSCÓPICA. AGENTEDEDIAGNÓSTICOSPARA USO IN VITRO. PARA USO EXCLUSIVO ENLABORATORIOS CLÍNICOS O DE GABINETES.

English

THE EUROLINES ASSAY IS FOR THE QUALITATIVE INVITRO DETERMINATION OF HUMAN ANTIBODIES OF THE IMMUNOGLOBULIN IGG CLASS AGAINST THE 2 ANTIGENS: MYELOPEROXIDASE (MPO) AND PROTEINASE 3 (PR3) IN SERUM OR PLASMA FOR THE DIAGNOSIS OF GRANULOMATOSIS WITH POLYANGIITIS(DEWEGENER)(GPA) AND MICROSCOPIC ARTERITIS. DIAGNOSTIC AGENTFOR IN VITRO USE. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DEDIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYOPARADETERMINACIÓNDE ANTICUERPOS HUMANOSIGG CONTRAMIELOPEROXIDASA YPROTEINASA 3.
Trade Name (English)
ASSAY FOR DETERMINATION OF HUMAN ANTIBODIES IGG AGAINST MYELOPEROXIDASE AND PROTEINASE 3.
Registration Information
Analysis ID
704R2022 SSA
Registration Date
July 29, 2022
Manufacturer / Fabricante
Name (Spanish)
INOCHEM S.A. DE C.V.
Name (English)
INOCHEM S.A. DE C.V.