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The OSOM® Mono Testa simple, in-office test for the detection of Infectious Mononucleosis.
It is CLIA waived (whole blood). Easy to read two color results with 100% sensitivity, 99% specificity, Result in five minutes, 12 month room temperature storage.
Product Specifications
Performance Characteristics: The OSOM® Mono Test utilizes color immunochromatographic technology for the qualitative detection of infectious mononucleosis heterophile antibodies.
Test Method: Lateral flow
Reagents: Diluent, positive and negative control
Specimen Type: Serum, plasma or whole blood
Time to Result: Read at 5 minutes
Sensitivity: 100%
Specificity: 96%
Shelf Life: 12 months from date of manufacturer
Procedure: Full color procedure for reference
Controls: Positive & Negative Controls
Tests: 25/ per case
FDA 510K & CLIA Waived for Whole Blood
CPT*: 86308 ($7.23) Serum/Plasma
86308QW* ($7.23) Whole Blood
Note: It is Health Care Providers responsibility to get reimbursements, as these are average and vary from state to state.
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