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The Food and Drug Administration (FDA) and Center for Biologics Evaluation and Research (CBER) define an IVD as: In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae

Without adequate glutathione to neutralize the ongoing flood of free radicals, the mitochondriathe powerhouses of the cellbecome damaged and dysfunctional

The heavy subunit (molecular weight about 73 kDa) exhibits the catalytic activity of the native enzyme and is also responsible for the feedback inhibition by GSH

Zhao et al., 2016)