1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 862
  5. subpart B
  6. § 862.1295

View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 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.

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

AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

SOURCE: 52 FR 16122, May 1, 1987, unless otherwise noted.

CITE AS: 21 CFR 862.1295