OSOM Mono Test, Plus Contains 2 Additional Test Sticks For External QC Testing, CLIA Waived/Moderate, Box/25 test

SEKISUI Diagnostics LLC

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Product Overview

The OSOM Mono Test w/Controls is FDA-cleared with no age restrictions and CLIA-waived for whole blood. It is designed for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, or plasma. The new plastic sample transfer pipettes are more secure.

Product Features

  • CLIA waived for whole blood.
  • FDA cleared
  • Sold by the kit
  • 25-test set (2 Additional test sticks for external QC)
  • Convenient room temperature storage
  • Results from a single reagent method can be obtained in 3–8 minutes.
  • Fingerstick for whole blood convenience.
  • New plastic sample transfer

Product Specifications

Catalog Number/SKU MF-SKS-145
CLIA Wave Yes
Test Type Mono
QC Included 2 Additional test sticks for external QC
Rapid Test Yes
Result Time 3-8 minutes
Sensitivity / Specificity > 99% sensitivity / 96% specificity
QTY 25 Mono Tests per kit
Age Limitation  No age limitation