Tellgen Corporation (SZSE: 300642) has announced that its controlling subsidiary, Shanghai Maishi Biotechnology Co., Ltd., recently had its medical device registration application accepted for review by the Shanghai Municipal Drug Administration.
The product in question, an assay kit for measuring four anti-epileptic drug concentrations using liquid chromatography-tandem mass spectrometry, is designed to detect the levels of valproic acid, oxcarbazepine metabolite (10,11-dihydro-10-hydroxycarbamazepine), topiramate, and levetiracetam in human serum samples.
Clinically, this kit facilitates the therapeutic drug monitoring of these four substances, aiding in the adjustment and management of patient treatment regimens.