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ETI-HA-IGMK PLUS. - COFEPRIS Registration 2565R2018 SSA

Access comprehensive regulatory information for ETI-HA-IGMK PLUS. (ETI-HA-IGMK PLUS.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2565R2018 SSA and manufactured by DIASORIN MÉXICO, S.A. DE C.V.. The device was registered on November 07, 2018.

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
2565R2018 SSA
ETI-HA-IGMK PLUS.
COFEPRIS Analysis ID: 2565R2018 SSA
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Product Use / Uso del Producto
Spanish

EL ETI-HA-IGML PLUS ES UN ENSAYO INMUNOENZIMÁTICO NO COMPETITIVO CON CAPTURA DE ANTICUERPOS, BASADO EN EL EMPLEO DE POCILLOS DE POLIESTIRENO RECUBIERTOS CON ANTICUERPO MONOCLONAL DE RATÓN DIRIGIDO CONTRA IGM HUMANA Y DE UN TRAZADOR ENZIMÁTICO, CONSTITUIDO

English

ETI-HA-IGML PLUS IS A NON-COMPETITIVE ENZYME-LINKED IMMUNOASSAY WITH ANTIBODY CAPTURE, BASED ON THE USE OF POLYSTYRENE WELLS COATED WITH MOUSE MONOCLONAL ANTIBODY DIRECTED AGAINST HUMAN IGM AND AN ENZYME TRACER, CONSISTING OF

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)
PROCEDIMIENTO PARA LA DETERMINACIÓN CUALITATIVA DE LA INMUNOGLOBULINA IGM DIRIGIDA CONTRA EL VIRUS D
Trade Name (English)
PROCEDURE FOR THE QUALITATIVE DETERMINATION OF IGM IMMUNOGLOBULIN DIRECTED AGAINST THE D VIRUS
Registration Information
Analysis ID
2565R2018 SSA
Registration Date
November 07, 2018
Manufacturer / Fabricante
Name (English)
DIASORIN MÉXICO, S.A. DE C.V.