21 CFR 864.7250 — Assay, Erythropoietin
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7250
Identification
A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.
Classification Rationale
Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GGT | Assay, Erythropoietin | 2 | 20 | 3rd Party |
Special Controls
GGT — Assay, Erythropoietin
*Classification.* Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
eCFR
GGT — Assay, Erythropoietin
The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
Ecfr Llm
