21 CFR 864.7375 — Glutathione, Red-Cell
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7375
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GII | Glutathione, Red-Cell | 2 | 0 | |
| JMH | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase | 2 | 0 | |
| KQF | Assay, Glutathione Reductase | 2 | 0 |
Special Controls
GII — Glutathione, Red-Cell
*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.
eCFR
JMH — Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase
*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.
eCFR
KQF — Assay, Glutathione Reductase
*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.
eCFR
