Saudi Arabia SFDA registration ME0000002950SFDAA00007
Quinidine
Saudi Arabia·Chemicals·Microgenics Corporation·General IVD(Others)ActiveProduct information
For Quantitative determination of quinidine in human serum
or plasma
Product use
The MULTIGENT Quinidine assay is intended for the
quantitative determination of quinidine in human serum
or plasma on the ARCHITECT c Systems and the
AEROSET System. The results obtained are used in
the diagnosis and treatment of quinidine overdose and
in monitoring levels of quinidine to help ensure
appropriate therapy.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000002950SFDAA00007
- Authorization ID
- GHTF-2019-2933
- Status
- Active
- Expire Date
- September 12, 2022
Manufacturer
- Manufacturer Name
- Microgenics Corporation
Model information
- Model ID(s)
- 6L31-20
Product accessories
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About this record
Access comprehensive regulatory information for Quinidine 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 ME0000002950SFDAA00007 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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