§862.1295. Folic acid test system.
21 C.F.R. § 862.1295
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.
Classification. Class II.
Notes, amendments, and revision history
Amendments
[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, 1988]