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IMTEC-ANA-LIA - COFEPRIS Registration 281R2018 SSA

Access comprehensive regulatory information for IMTEC-ANA-LIA (IMTEC-ANA-LIA) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 281R2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on January 30, 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
281R2018 SSA
IMTEC-ANA-LIA
COFEPRIS Analysis ID: 281R2018 SSA
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Product Use / Uso del Producto
Spanish

EL IMTEC-ANA-LIA ES UN INMUNOENSAYO ENZIMÁTICO INDIRECTO BASADO EN MEMBRANA (LIA) PARA LA MEDICIÓN CUALITATIVA DE ANTICUERPOS DE CLASE IGG CONTRA NUCLEOSOMA, ADNDC, HISTONA, SMD1, U1SNRNP, SS-A/RO 60, SS-A/RO 52,SS-B/ LA, SCI70, CENP-B, JO1 Y PROTEÍNA P R

English

IMTEC-ANA-LIA IS A MEMBRANE-BASED INDIRECT ENZYME IMMUNOASSAY (LIA) FOR THE QUALITATIVE MEASUREMENT OF IGG CLASS ANTIBODIES AGAINST NUCLEOSOME, CNAD, HISTONE, SMD1, U1SNRNP, SS-A/RO 60, SS-A/RO 52,SS-B/ LA, SCI70, CENP-B, JO1 AND PROTEIN P R

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 ANTINUCLÉICOS
Trade Name (English)
LINEAR IMMUNOASSAY FOR THE DETECTION OF ANTINUCLEIC ANTIBODIES
Registration Information
Analysis ID
281R2018 SSA
Registration Date
January 30, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.