US FDA Registered Establishment #1641328 Automated RPR Test Kit Certifications CPT Code 86592 (Screening) CPT Code 86593 (Titers) FDA 510(k) K173376 FDA 510(k) BK170114 FDA 510(k) K182391 FDA 510(k) BK200488 FDA 510(k) K201438 FDA 510(k) BK200539 Sensitivity & Specificity Sensitivity: >99% Specificity: >99% Diagnostic Tests 480 Test Kit (#900480D) 4800 Test Kit (#9004800D) Blood Bank and Tissue Tests 480 Test Kit (#900480ABB) 4800 Test Kit (#9004800ABB) Automated Control Sets (Sold separately) 2.5 ml (#905002.5A) 5.0 ml (#905005A Arlington Scientific’s Automated RPR Syphilis Test is FDA cleared for diagnostic, blood donor screening and cadaveric RPR testing, for use on the ASI Evolution® Automated Syphilis Analyzer. Nontreponemal tests, such as the ASI Automated RPR test, are more reliable indicators of untreated syphilis infections and are used to monitor response to treatment or to indicate new infections.¹ Syphilis, if left untreated, can be fatal. Now diagnostic labs, blood banks and tissue banks have an automated RPR syphilis test that uses the CDC’s recommended traditional algorithm for syphilis screening.² The ASI Evolution and the Automated RPR test kit offers diagnostic and blood donor screening labs a budget friendly system that will improve workflow efficiencies, reduce labor costs, and provide consistent, dependable, and objective results. Features A CDC recommended primary screening test for Syphilis Standardized methodology Run 190 tests/hour Titers up to 1:2048 Data management (analyze, archive and retrieve) Simple and economical to use Reduce labor Improve efficiency Fifteen minutes to first result Made in the USA https://www.cdc.gov/std/stats18/syphilis.htm https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5732a2.htm DOCUMENTATION WHY NONTREPONEMAL SYPHILIS INFORMATION CLSI BLOOD BANK AND TISSUE CLSI DIAGNOSTIC CLSI CONTROLS BLOOD BANK/CADAVERIC INSERT DIAGNOSTIC INSERT SAFETY DATA SHEET SAFETY DATA SHEET - DILUENT CONTACT US ABOUT US NEWS & EVENTS POLICIES 1840 North Technology Drive Springville, UT 84663 800-654-0146, 801-489-8911 info@arlingtonscientific.com Copyright © 2021- All rights reserved.