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ASiManager-AT™

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)

Image of the ASiManager-AT. FDA cleared for diagnostic testing, blood and cadaveric donor screening.

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.

Features

  • Objective and standardized interpretation
  • Data management
  • Utilizes ASI RPR Card Test for Syphilis
  • Easy-to-use
  • Cost effective
  • Lowest cost per test
  • Increased reliability
  • Optimize Labor Resources
  • Workflow Improvement
  • Network/LIMS capable
  • Laboratory proven
  • Results providers know and trust
  • Throughput- 450 samples/hour
  • FDA 510(k) Cleared for in vitro diagnostic and blood donor and cadaveric screening!

Certifications

  • 510(k)-BK130001
  • 510(k)-K111356
  • 510(k)-BK140192
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Rev. 03_2016  CR1134

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