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e-CFR data is current as of September 18, 2020

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1455


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§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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