US FDA Registered Establishment #1641328 EVALUATION KITS Color Mono II Certifications CPT Code 86308 510(k)-K821386 Sensitivity & Specificity Sensitivity: 1:28 Davidsohn titer Specificity: >95% Test Kit Sizes 25 test kit #450025 50 test kit #450050 100 test kit #450100 1000 test kit #4501000 The ASI Color Mono II Test is a simple color-enhanced agglutination test for the qualitative and semiquantitative detection of heterophil antibodies in human serum or EDTA plasma associated with infectious mononucleosis (IM). No initial dilution of patient sample is required for this test. The presence of IM antibodies in serum or plasma at detectable levels will interact with the sensitized particles to produce a visible red agglutination with a blue background, which is a positive result. Features Easy to read results in 2 minutes Color enhanced agglutination test Qualitative and semiquantitative procedures All testing materials needed to perform the test included in each kit Can be used with serum or plasma Color-coded reactive and nonreactive controls with dropper tip vials included in the kit. Storage requirement: 2-8ºC Longest shelf life - up to 24 Months Qualitative and semiquantitative procedures DOCUMENTATION SAFETY DATA SHEET CLSI PRODUCT INSERT MATERIALS PROVIDED PROCEDURES & INTERPRETATION WHAT IS INFECTIOUS MONO 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.