Mmp-9 Test System
The MMP-9 Test System is a visual, qualitative immunoassay intended for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye disease. It is an FDA Class 1 device regulated under 21 CFR 862.1540, subject to general controls, within the Clinical Chemistry (CH) specialty. The product code is PFQ, and it is eligible for third-party review. This device is non-implantable and not life-sustaining.
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Basic Information
- Product Code
- PFQ
- Device Class
- FDA class 1
- Regulation Number
- 862.1540
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K132066 | INFLAMMA DRY | Nov 21, 2013 | Substantially Equivalent | Rapid Pathogen Screening, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.