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CREATINE KINASE - COFEPRIS Registration 642R2022 SSA

Access comprehensive regulatory information for CREATINE KINASE (CREATINE KINASE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 642R2022 SSA and manufactured by ABBOTTLABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on July 19, 2022.

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
642R2022 SSA
CREATINE KINASE
COFEPRIS Analysis ID: 642R2022 SSA
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Product Use / Uso del Producto
Spanish

ENSAYO PARA LA DETERMINACIÓN CUANTITATIVA DECREATINACINASAENSUEROOPLASMAHUMANOS,ENLOSANALIZADORESARCHITECTCSYSTEMS.UTILIZADOPARAELDIAGNÓSTICO Y EL TRATAMIENTO DE ENFERMEDADESASOCIADASCONELMÚSCULOESQUELÉTICO,ELCORAZÓN,ELSISTEMANERVIOSOCENTRALYELTIROIDES. AGENTESDEDIAGNÓSTICOPARAUSOINVITRO.PARAUSOEXCLUSIVOEN LABORATORIOS CLÍNICOS O DE GABINETES.

English

ASSAY FOR THE QUANTITATIVE DETERMINATION OF CREATINE KINASE IN HUMAN SERUM OR PLASMA, IN ARCHITECTCSYSTEMS ANALYZERS. USED FOR THE DIAGNOSIS AND TREATMENT OF DISEASES ASSOCIATED WITH THE SKELETAL MUSCLE, HEART, CENTRAL NERVOUS SYSTEM AND THYROID. Diagnostic agents for use in the hospital. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DEDIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
ENSAYO PARA LADETERMINACIÓNDECREATINAKINASA (CK)
Trade Name (English)
CREATINE KINASE (CK) ASSAY
Registration Information
Analysis ID
642R2022 SSA
Registration Date
July 19, 2022
Manufacturer / Fabricante
Name (English)
ABBOTTLABORATORIES DE MÉXICO, S.A. DE C.V.