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Tag Archives: CD Diagnostics

FDA permits marketing of prosthetic joint infection test

September 2019—The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit (CD Diagnostics) as an aid for the detection of periprosthetic joint infection in the synovial fluid of patients being evaluated for revision surgery. The test kit detects human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes. The test is not intended to identify a specific type of infection.

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