Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 862  /  Sec. 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid

(a) Identification. A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.

(b) Classification. Class II.