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DIMENSION® CLINICAL CHEMISTRY SYSTEMS URINE METHADONE SCREEN FLEX® REAGENT CARTRIDGE - COFEPRIS Registration 1971R2019 SSA

Access comprehensive regulatory information for DIMENSION® CLINICAL CHEMISTRY SYSTEMS URINE METHADONE SCREEN FLEX® REAGENT CARTRIDGE (DIMENSION® CLINICAL CHEMISTRY SYSTEMS URINE METHADONE SCREEN FLEX® REAGENT CARTRIDGE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1971R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.. The device was registered on October 10, 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
1971R2019 SSA
DIMENSION® CLINICAL CHEMISTRY SYSTEMS URINE METHADONE SCREEN FLEX® REAGENT CARTRIDGE
COFEPRIS Analysis ID: 1971R2019 SSA
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Product Use / Uso del Producto
Spanish

PRUEBA ANALÍTICA PRELIMINAR DE DIAGNÓSTICO IN VITRO PARA LA DETERMINACIÓN CUALITATIVA Y SEMICUANTITATIVA DE METADONA EN ORINA HUMANA PARA DETECTAR EL USO O LA SOBREDOSIS DE METADONA, ASÍ COMO PARA DETERMINAR LA COMPATIBILIDAD CON EL TRATAMIENTO DE MANTENI

English

PRELIMINARY ANALYTICAL IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE AND SEMI-QUANTITATIVE DETERMINATION OF METHADONE IN HUMAN URINE TO DETECT METHADONE USE OR OVERDOSE AND TO DETERMINE COMPATIBILITY WITH METHADONE TREATMENT

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)
REACTIVO PARA LA DETERMINACIÓN DE METADONA
Trade Name (English)
REAGENT FOR THE DETERMINATION OF METHADONE
Registration Information
Analysis ID
1971R2019 SSA
Registration Date
October 10, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.