| Proprietary Device Name: | AMNIO-STAT-FLM |
| Common Generic Device Name: | SLIDE AGGUTINATION ASSAY FOR PHOSPHATIDYLGLYCEROL |
| Classification Name: | CHROMATOGRAPHIC SEPARATION, LECITHIN/SPHINGOMYELIN RATIO |
| FDA Regulation Number: | 862.1455 |
| Product Differentiation: | |
| Product Website: |