§ 862.1455. Lecithin/sphingomyelin ratio in amniotic fluid test system.
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/us/cfr/t21/s§ 862.1455·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.