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Immunoassay For Detection Of Amniotic Fluid Protein(S).

FDA product code NQM · 2 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.1550
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-01-09 – 2011-11-23

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.

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