21 C.F.R. § 862.1455

Current through September 30, 2024
Section 862.1455 - Lecithin/sphingomyelin ratio in amniotic fluid test system
(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.

21 C.F.R. § 862.1455