Saudi Arabia SFDA registration ME0000002950SFDAA00018
Theophylline
Saudi Arabia·Chemicals·Microgenics Corporation·General IVD(Others)ActiveProduct information
For the quantitative
measurement of theophylline in human serum or plasma
Product use
The Theophylline assay is for in vitro diagnostic use for the quantitative
measurement of theophylline in human serum or plasma on the ARCHITECT c Systems. The measurements obtained are used in the
diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure appropriate therapy
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000002950SFDAA00018
- Authorization ID
- GHTF-2018-2104
- Status
- Active
- Expire Date
- November 10, 2023
Manufacturer
- Manufacturer Name
- Microgenics Corporation
Model information
- Model ID(s)
- 5P06-21
Product accessories
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About this record
Access comprehensive regulatory information for Theophylline 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 ME0000002950SFDAA00018 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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