# Amniotic Fluid Protein Immunoassay
> **Product code: PDS** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1550
## Classification
- **FDA Product Code:** PDS
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.1550
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

To detect specified amniotic fluid proteins in cervicovaginal samples

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PDS)
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