Intended for the assessment of bacterial protease activity in chronic wounds.

Intended for the assessment of bacterial protease activity in chronic wounds.
WOUNDCHEK™ Bacterial Status - 360006US

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of protease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QFA

Device Name: Assay For Detection Of Proteases In Chronic Wounds

Device Class: 2

Physical State: Swab to collect wound fluid that is then mixed with a substrate and added to a lateral flow device for detection of enzymatic activity

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.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Detection of enzymatic activity

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Various - Skin (chronic wounds)

Regulation Number: 866.3231

Third Party Flag: N

Medical Specialty: MI

Device Id: 10811877011245

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A