NQM

Immunoassay For Detection Of Amniotic Fluid Protein(S).

Product code

NQM

Device name

Immunoassay For Detection Of Amniotic Fluid Protein(S).

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 test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.

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