OAM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoassay, Insulin-Like Growth Factor Binding Protein-1
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Medical specialty
- Clinical Chemistry
- FDA definition
- The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.
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| Record | Firm | Date |
|---|---|---|
| ACTIM PROM (K123986) | Alere Scarborough, Inc. | 2014-01-09 |
| ACTIM PROM AND CONTROLS (K061886) | Medix Biochemica | 2007-01-25 |
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