Lecithin/sphingomyelin ratio in amniotic fluid test system.

21 C.F.R. § 862.1455
in effectEffective: 2024-07-01
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(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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