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INNOVANCE® DTI ASSAY - COFEPRIS Registration 1886R2019 SSA

Access comprehensive regulatory information for INNOVANCE® DTI ASSAY (INNOVANCE® DTI ASSAY) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1886R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.. The device was registered on September 19, 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 II
1886R2019 SSA
INNOVANCE® DTI ASSAY
COFEPRIS Analysis ID: 1886R2019 SSA
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Product Use / Uso del Producto
Spanish

INNOVANCE® DTI ASSAY ES UN ENSAYO CROMOGÉNICO COMPETITIVO PARA LA MEDICIÓN CUANTITATIVA IN-VITRO DE INHIBIDORES DIRECTOS DE TROMBINA. LOS INHIBIDORES DIRECTOS DE TROMBINA SE MIDEN EN PLASMA HUMANO CITRATADO CON UN MÉTODO AUTOMATIZADO PARA AYUDAR EN LA DET

English

INNOVANCE® DTI ASSAY IS A COMPETITIVE CHROMOGENIC ASSAY FOR QUANTITATIVE IN-VITRO MEASUREMENT OF DIRECT THROMBIN INHIBITORS. DIRECT THROMBIN INHIBITORS ARE MEASURED IN CITRATE HUMAN PLASMA WITH AN AUTOMATED METHOD TO AID IN DET

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO CROMOGÉNICO
Trade Name (English)
CHROMOGENIC ASSAY
Registration Information
Analysis ID
1886R2019 SSA
Registration Date
September 19, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.