FDA clears WOUNDCHEK™ Bacterial Status for use by wound care professionals
Date: Dec 2, 2019
Woundchek Laboratories are excited to announce that the FDA has cleared Bacterial Status for use in the USA by health care professionals whose clinical practice primarily or routinely involves the assessment and treatment of chronic wounds. Bacterial Status results are intended for use in conjunction with the assessment of other known risk factors for wound healing that significantly contribute to the assessment of risk for non-healing chronic wounds such as wound age, wound size, and vascular status.
Bacterial Status is intended for use in adult patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where patients are asymptomatic for clinical signs of infection. The test is intended for use with chronic wounds that are between 21 days and < 6 months of age and chronic wounds that are > 6 months of age that are < 1cm2 in size.