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ARCHITECT DIBUCAINE CHE. - COFEPRIS Registration 1853R2021 SSA

Access comprehensive regulatory information for ARCHITECT DIBUCAINE CHE. (ARCHITECT DIBUCAINE THAT.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1853R2021 SSA and manufactured by ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on November 16, 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.

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COFEPRIS Official Data
Clase I
1853R2021 SSA
ARCHITECT DIBUCAINE CHE.
COFEPRIS Analysis ID: 1853R2021 SSA
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Product Use / Uso del Producto
Spanish

ELENSAYODIBUCAINECHESEUTILIZACONELENSAYOCHOLINESTERASE(CHE)PARALADETERMINACIÓN DEL NÚMERO DECINCOCAÍNA (NC) CON SUSTRATO DEBUTIRILTIOCOLINAENSUEROOPLASMAENARCHITECT C SYSTEMS. AGENTE DEDIAGNÓSTICOPARAUSOINVITRO. PARAUSOEXCLUSIVO EN LABORATORIOS CLÍNICOS ODE GABINETE.

English

THE DIBUCAINECHESE ASSAY USED THE CHOLINESTERASE(CHE) ASSAY FOR THE DETERMINATION OF THE DECINCOCAINE (NC) NUMBER WITH DEBUTIRILTIOCHOLINE SUBSTRATE IN SERUM OR PLASMA IN ARCHITECT C SYSTEMS. DIAGNOSTIC AGENTFORUSEINVITRO. FOR EXCLUSIVE USE IN CLINICAL LABORATORIES OR CABINET.

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 DELNÚMERO DE CINCOCAÍNA (NC) CONSUSTRATO DE BUTIRILTIOCOLINA.
Trade Name (English)
ASSAY FOR THE DETERMINATION OF THE NUMBER OF CINCOCAINE (CN) WITH BUTYRILTHIOCHOLINE SUBSTRATE.
Registration Information
Analysis ID
1853R2021 SSA
Registration Date
November 16, 2021
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.