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Ecstasy - SFDA Registration ME0000002950SFDAA00001

Access comprehensive regulatory information for Ecstasy in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000002950SFDAA00001 and manufactured by Microgenics Corporation.

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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General IVD(Others)
ME0000002950SFDAA00001
Ecstasy
SFDA Registration: ME0000002950SFDAA00001
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Product Information

Reagent for Ecstasy

Product Use

The MULTIGENT Ecstasy assay is intended for the qualitative and semiquantitative determination of ecstasy in human urine on the ARCHITECT c Systems. The cutoff for the qualitative application is 500 ng/mL. The assay is intended for use in clinical laboratories. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.1,2 Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002950SFDAA00001
Authorization ID
GHTF-2019-2933
Status
Active
Expire Date
September 12, 2022
Manufacturer
Manufacturer Name
Microgenics Corporation
Model Information
Model ID(s)
3L42-20
Product Accessories

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