FDA CBER Clears ASI™ Syphilis Method with a Cadaveric Specific Claim
The FDA (CBER) has cleared the ASiManager-AT™ as the first and only method for the interpretation and screening for in vitro diagnostics, blood donor and cadaveric (non-heart beating) donor screening. (510(k)-BK140192)
ASI™ Receives First and Only FDA CBER Cadaveric Donor Clearance for Syphilis Screening
The United States Food and Drug Administration (FDA) grants CBER clearance for the first and only syphilis method for the interpretation and screening of cadaveric (non-heart beating) donors using the ASI™ RPR Card Test for Syphilis and the ASiManager-AT™ digital analyzer.