JHH · Electrophoretic Method, Lecithin/Sphingomyelin Ratio
Clinical Chemistry · 21 CFR 862.1455 · Class 2
Overview
| Product Code | JHH |
|---|---|
| Device Name | Electrophoretic Method, Lecithin/Sphingomyelin Ratio |
| Regulation | 21 CFR 862.1455 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
