OAM

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Product code

OAM

Device name

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Device class

Class 1

21 CFR

21 CFR 862.1550

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).