21 C.F.R. § 864.7250 Erythropoietin assay.
Title 21 - Food and Drugs
(a) 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. (b) Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).” [45 FR 60612, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, 2000]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7250 Erythropoietin assay.
