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)
FDA Cleared Nontreponemal RPR Analyzer for Diagnostic Testing, Blood and Cadaveric Donor Screening
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CBER INFORMATION AND TECHNICAL DOCUMENTS
World's First Nontreponemal RPR Analyzer
Arlington Scientific, Inc.™ brings state-of-the-art digital technology to laboratory analysis, interpretation and management of ASI serology agglutination tests. The ASiManager-AT™ is a integrated digital particle analyzer that objectively interprets the ASI RPR Card Test for Syphilis. The Analyzer utilizes the proprietary ASI Agglutination Serology Interpretation software and ASI reagents. Laboratories can now follow the CDC recommended nontreponemal algorithm (RPR/VDRL) while providing objective, standardized test interpretation and realize the benefits of automation and data management.