GII · Glutathione, Red-Cell
Hematology · 21 CFR 864.7375 · Class 2
Overview
| Product Code | GII |
|---|---|
| Device Name | Glutathione, Red-Cell |
| Regulation | 21 CFR 864.7375 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A glutathione reductase assay is a device used to determine the activity of the enzyme glutathione reductase in serum, plasma, or erythrocytes by such techniques as fluorescence and photometry. The results of this assay are used in the diagnosis of liver disease, glutathione reductase deficiency, or riboflavin deficiency.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Cleared Devices (0)
No cleared devices on record.
