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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeQFA
Regulation Number 866.3231
Device Class 2


Premarket Reviews
ManufacturerDecision
ALERE SCARBOROUGH, INC.
  GRANTED 1

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