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ALINITY C BENZODIAZEPINES. - COFEPRIS Registration 1850R2021 SSA

Access comprehensive regulatory information for ALINITY C BENZODIAZEPINES. (ALINITY C BENZODIAZEPINES.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1850R2021 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
1850R2021 SSA
ALINITY C BENZODIAZEPINES.
COFEPRIS Analysis ID: 1850R2021 SSA
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Product Use / Uso del Producto
Spanish

ALINITY C BENZODIAZEPINES ES UNENZIMOINMUNOANÁLISIS HOMOGÉNEOQUESE UTILIZA PARA LA DETERMINACIÓNCUALITATIVA O SEMICUANTITATIVA DEBENZODIAZEPINAS Y SUS METABOLITOS ENORINAHUMANAAUNACONCENTRACIÓNDEPUNTO DE CORTE EN 200 NG/ML (0.700ΜMOL/L)ENELANALIZADORALINITYC.ALINITY C BENZODIAZEPINES QUALCALIBRATOR SE UTILIZA PARA LACALIBRACIÓN DEL ENSAYO ALINITY CBENZODIAZEPINES, QUE DETECTABENZODIAZEPINASENORINAHUMANAENELANALIZADOR ALINITY C. ALINITY C

English

ALINITY C BENZODIAZEPINES IS A HOMOGENEOUS ENZYME IMMUNOASSAY USED FOR THE QUALITATIVE OR SEMI-QUANTITATIVE DETERMINATION OF BENZODIAZEPINES AND THEIR METABOLITES IN HUMAN URINE AT A CUT-OFF CONCENTRATION OF 200 NG/ML (0.700ΜMOL/L) IN THE LINITYC ANALYSER. ALINITY C BENZODIAZEPINES QUALCALIBRATOR IS USED FOR THE CALIBRATION OF THE ALINITY CBENZODIAZEPINES ASSAY, WHICH DETECTS BENZODIAZEPINES IN HUMAN URINE IN THE ALINITY C. ALINITY C 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 DETERMINACIÓNCUALITATIVA O SEMICUANTITATIVA DEBENZODIAZEPINAS Y SUS METABOLITOS.
Trade Name (English)
ASSAY FOR THE QUALITATIVE OR SEMI-QUANTITATIVE DETERMINATION OF BENZODIAZEPINES AND THEIR METABOLITES.
Registration Information
Analysis ID
1850R2021 SSA
Registration Date
November 16, 2021
Manufacturer / Fabricante
Name (English)
ABBOTT LABORATORIES DEMÉXICO, S.A. DE C.V.