PFQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mmp-9 Test System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1540
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| INFLAMMA DRY (K132066) | Rapid Pathogen Screening, Inc. | 2013-11-21 |
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