# Immunoassay For Detection Of Amniotic Fluid Protein(S).
> **Product code: NQM** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1550
## Classification
- **FDA Product Code:** NQM
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.1550
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NQM)
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