FDA Product Code OAM: Immunoassay, Insulin-like Growth Factor Binding Protein-1
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.
Leading manufacturers include Alere Scarborough, Inc..
2
Total
2
Cleared
293d
Avg days
2007
Since
FDA 510(k) Cleared Immunoassay, Insulin-like Growth Factor Binding Protein-1 Devices (Product Code OAM)
2 devices