PDS

Amniotic Fluid Protein Immunoassay

Product code

PDS

Device name

Amniotic Fluid Protein Immunoassay

Device class

Class 1

21 CFR

21 CFR 862.1550

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

To detect specified amniotic fluid proteins in cervicovaginal samples

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