Product code QFA— Microbiology
WOUNDCHEK Bacterial Status
- Classification name
- Assay For Detection Of Proteases In Chronic Wounds
- Device class
- Class 2
- Regulation
- 21 CFR 866.3231
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QFA
FDA has cleared device under product code QFA, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QFA
Recent clearances under product code QFA
Data sourced from openFDA. This site is unofficial and independent of the FDA.