# Mmp-9 Test System
> **Product code: PFQ** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1540
## Classification
- **FDA Product Code:** PFQ
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.1540
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 6
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PFQ)
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