Product code PFQ
- Device name
- Mmp-9 Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1540
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset