Saudi Arabia SFDA registration ME0000002950SFDAA00001
Ecstasy
Saudi Arabia·Chemicals·Microgenics Corporation·General IVD(Others)ActiveProduct 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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About this record
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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