Saudi Arabia SFDA registration ME0000002950SFDAA00180
Phenytoin
Saudi Arabia·Chemicals·Microgenics Corporation·General IVD(Others)ActiveProduct information
For the quantitative
measurement of phenytoin in human serum or plasma
Product use
The Phenytoin assay is for in vitro diagnostic use for the quantitative
measurement of phenytoin in human serum or plasma on the ARCHITECT c Systems. The measurements obtained are used in the
diagnosis and treatment of phenytoin overdose and in monitoring levels
of phenytoin to help ensure appropriate therapy.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000002950SFDAA00180
- Authorization ID
- GHTF-2018-2104
- Status
- Active
- Expire Date
- November 10, 2023
Manufacturer
- Manufacturer Name
- Microgenics Corporation
Model information
- Model ID(s)
- 5P08-21
Product accessories
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About this record
Access comprehensive regulatory information for Phenytoin 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 ME0000002950SFDAA00180 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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