21 C.F.R. § 862.1295

Current through October 31, 2024
Section 862.1295 - Folic acid test system
(a)Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.
(b)Classification. Class II.

21 C.F.R. §862.1295

52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988