Immunoassay For Detection Of Amniotic Fluid Protein(S).
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
Ineligible
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.