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ALINITY I PIVKA-II. - COFEPRIS Registration 2286R2019 SSA

Access comprehensive regulatory information for ALINITY I PIVKA-II. (ALINITY I PIVKA-II.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2286R2019 SSA and manufactured by ABBOTT LABORATORIES DE MÉXICO, S.A. DE C.V.. The device was registered on December 13, 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 I
2286R2019 SSA
ALINITY I PIVKA-II.
COFEPRIS Analysis ID: 2286R2019 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO ALINITY I PIVKA-II (PROTEÍNA INDUCIDA POR LA AUSENCIA DE VITAMINA K O ANTAGONISTA-II) ES UN INMUNOANÁLISIS QUIMIOLUMINISCENTE DE MICROPARTÍCULAS (CMIA) PARA LA DETERMINACIÓN CUANTITATIVA DE PIVKA-II EN SUERO O PLASMA HUMANOS EN EL ANALIZADOR ALI

English

THE ALINITY I PIVKA-II ASSAY (VITAMIN K-INDUCED PROTEIN OR ANTAGONIST-II) IS A MICROPARTICLE CHEMILUMINESCENT IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF PIVKA-II IN HUMAN SERUM OR PLASMA ON THE ALI ANALYZER

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)
ENSAYO PARA LA DETERMINACIÓN DE PIVKA-II.
Trade Name (English)
TEST FOR THE DETERMINATION OF PIVKA-II.
Registration Information
Analysis ID
2286R2019 SSA
Registration Date
December 13, 2019
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DE MÉXICO, S.A. DE C.V.