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IMTEC-MYOSITIS-LIA PL - COFEPRIS Registration 523R2018 SSA

Access comprehensive regulatory information for IMTEC-MYOSITIS-LIA PL (IMTEC-MYOSITIS-LIA PL) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 523R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on February 23, 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
523R2018 SSA
IMTEC-MYOSITIS-LIA PL
COFEPRIS Analysis ID: 523R2018 SSA
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Product Use / Uso del Producto
Spanish

EL IMTEC-MYOSITIS-LIA PL ES UN INMUNOENSAYO ENZIMÁTICO INDIRECTO BASADO EN MEMBRANA PARA LA MEDICIÓN CUALITATIVA DE ANTICUERPOS DE CLASE IGG CONTRA JO-1, MI-2, PM-SCL, U1-SNRNP, KU, PL-7, PL-12 EN SUERO O PLASMA HUMANO. EL ENSAYO HA SIDO DISEÑADO PARA E

English

IMTEC-MYOSITIS-LIA PL IS A MEMBRANE-BASED INDIRECT ENZYME IMMUNOASSAY FOR THE QUALITATIVE MEASUREMENT OF IGG CLASS ANTIBODIES AGAINST JO-1, MI-2, PM-SCL, U1-SNRNP, KU, PL-7, PL-12 IN HUMAN SERUM OR PLASMA. THE ASSAY HAS BEEN DESIGNED TO

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)
INMUNOENSAYO LINEAL PARA LA DETECCIÓN DE ANTICUERPOS EN LA MIOSITIS AUTOINMUNE INMUNOENSAYO LINEA
Trade Name (English)
LINEAR IMMUNOASSAY FOR THE DETECTION OF ANTIBODIES IN AUTOIMMUNE MYOSITIS IMMUNOASSAY LINE
Registration Information
Analysis ID
523R2018 SSA
Registration Date
February 23, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.