Immunoassay For Detection Of Amniotic Fluid Protein(S).
The immunoassay for detection of amniotic fluid proteins is a clinical chemistry device intended for use by healthcare professionals to aid in the detection of fetal membrane rupture (premature rupture of membranes) in pregnant women presenting with signs or symptoms suggestive of such rupture. It is classified as FDA Class 1 under regulation 862.1550 in the Clinical Chemistry specialty, and while Class 1 and 510(k) exempt (submission type 4), GMP requirements still apply. Product code NQM is not eligible for third-party review.
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Basic Information
- Product Code
- NQM
- Device Class
- FDA class 1
- Regulation Number
- 862.1550
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.