Title 21

SECTION 862.1455

862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.

§ 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.

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