Pure Global

ALINITYISTATCK-MBREAGENT KITALINITY I STAT CK-MB REAGENT KIT - COFEPRIS Registration 2219R2021 SSA

Access comprehensive regulatory information for ALINITYISTATCK-MBREAGENT KITALINITY I STAT CK-MB REAGENT KIT (ALINITYISTATCK-MBREAGENT KITALINITY I STAT CK-MB REAGENT KIT) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2219R2021 SSA and manufactured by ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on December 27, 2021.

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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase II
2219R2021 SSA
ALINITYISTATCK-MBREAGENT KITALINITY I STAT CK-MB REAGENT KIT
COFEPRIS Analysis ID: 2219R2021 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

• ALINITY I STAT CK-MB REAGENT KIT: ELENSAYO ALINITY I STAT CK-MB ES UNINMUNOANÁLISIS QUIMIOLUMINISCENTE DEMICROPARTÍCULAS (CMIA) UTILIZADO PARALA DETERMINACIÓN CUANTITATIVA DEISOZIMAMBDELACREATINACINASA(CK-MB)EN SUERO Y PLASMA HUMANOS EN ELANALIZADORALINITYI.ELENSAYOALINITYISTATCK-MBSEUTILIZACOMOAYUDAENELDIAGNÓSTICO DEL INFARTO DE MIOCARDIO(IM). •ALINITY I STAT CK-MB CALIBRATORS:LOSCALIBRADORESALINITYISTATCK-MBSEUTILIZAN PARA LA CALIBRACIÓN DEL ANALIZ

English

• ALINITY I STAT CK-MB REAGENT KIT: THE ALINITY I STAT CK-MB ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) USED FOR THE QUANTITATIVE DETERMINATION OF CREATINE KINA ISOZYME (CK-MB) IN HUMAN SERUM AND PLASMA IN THE LINITYI ANALYZER. THE ALINITYISTATCK-MB ASSAY IS USED AS AN AID IN THE DIAGNOSIS OF MYOCARDIAL INFARCTION (MI). •ALINITY I STAT CK-MB CALIBRATORS:ALINITYISTATCK-MBSE CALIBRATORS USED FOR ANALYZER CALIBRATION

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 PARA LA DETERMINACIÓNCUANTITATIVA DE ISOZIMA MB DE LA CREATINA CINASA (CK-MB)..
Trade Name (English)
ASSAY FOR THE QUANTITATIVE DETERMINATION OF CREATINE KINASE ISOZYME MB (CK-MB).
Registration Information
Analysis ID
2219R2021 SSA
Registration Date
December 27, 2021
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.