1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
  6. Subpart B - Clinical Chemistry Test Systems
  7. 21 CFR § 862.1455
21 CFR § 862.1455
Lecithin/sphingomyelin ratio in amniotic fluid test system
June 25, 2020
CFR

(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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§ 862.1450 Lactic acid test system
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§ 862.1460 Leucine aminopeptidase test system

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