QFA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay For Detection Of Proteases In Chronic Wounds
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3231
- Medical specialty
- Microbiology
- FDA definition
- A device to detect bacterial protease activity in chronic wound fluid is a lateral flow prescription device that may include a sterile swab. The device is intended for use in patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patient are asymptomatic for clinical signs of infection.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WOUNDCHEK Bacterial Status (DEN180014) | Alere Scarborough, Inc. | 2019-12-02 |
Track QFA automatically
Every clearance here is in the API, with alerts when new ones post.