21 CFR § 862.1295 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1295 Folic acid test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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]

← § 862.1290 Fatty acids test system.§ 862.1300 Follicle-stimulating hormone test system. →