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Phenytoin - SFDA Registration ME0000002950SFDAA00180

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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General IVD(Others)
ME0000002950SFDAA00180
Phenytoin
SFDA Registration: ME0000002950SFDAA00180
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Product 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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