Device |
assay for detection of proteases in chronic wounds |
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. |
Product Code | QFA |
Regulation Number |
866.3231
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Device Class |
2
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