Product code OAM

Device name

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

Medical specialty

Clinical Chemistry

Device class

1

Regulation number

862.1550

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset