21 C.F.R. § 862.1455

Lecithin/sphingomyelin ratio in amniotic fluid test system.

Last amended: 2016Year: 2026Length: 51 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.1455 (2026)

(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: Lecithin/sphingomyelin ratio in amniotic fluid test system. | Justis AI