Status™ Mono w/ controls (25 tests)

Immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma. Status Mono test qualitatively detects infectious mononucleosis antibodies in human whole blood, serum or plasma specimens. This test is intended for use as an aid in the diagnosis of infectious mononucleosis.   Product Specifications Sample type Whole blood, serum or plasma specimen collection Time to results 8 minutes With controls Sensitivity 99.9% / Specificity 98.8%  Whole blood only Sensitivity 99.9% / Specificity 98.3% Kit contents Test devices, Developer solution, Negative control, Positive control, Package insert, Procedure card, (10 µL) (black line) sample transfer pipettes for use with serum/plasma, (25µL) (red line) sample transfer pipettes for use with whole blood Storage 35-86°F (2-30°C) CLIA complexity Waived Certification FDA More Information Instructions of Use (IFU) Healthcare Provider