21 CFR § 862.1295
Folic acid test system
June 25, 2020
(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.
[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]