Item Brochure

A rapid test for the qualitative detection of Strep A antigen in
throat swab specimens.
Lateral flow immunoassay technology identifies antibodies
specific for whole cell Lancefield Group A Streptococcus to
selectively detect Strep A carbohydrate antigen in a throat
swab specimen. Aids in the early diagnosis of Group A
Streptococcal infection.
• 97% Sensitivity; 95% Specificity
• Accurate results in 5 minutes
• Quickly diagnose and treat infections to help avoid
serious complications
• CLIA waived and FDA 510(k) cleared to market
• Room temperature storage
CPT Code: 87880
Strep A Test
Item # Description
P080033 Strep A Test-Throat Swab Kit
Includes: 25 test strips, 25 swabs, 25 extraction tubes, 1-10mL
reagent A, 1-10mL reagent B, 1-1mL positive control, 1-1mL
negative control, package insert, procedure card. 25 tests per box
Rapid chromatographic immunoassay technology identifies
heterophile antibodies in whole blood, serum or plasma to aid in the
diagnosis of Infectious Mononucleosis.
• Qualitative membrane strip based immunoassay for detection
of IM heterophile antibodies
• All inclusive 20 test kit
• Simple to perform using whole blood (from venipucture or
fingerstick), serum or plasma
• Reliable results in 5 minutes
• CLIA waived for whole blood and FDA 510(k) cleared to market
Item # Description
P080016 Infectious Mononucleosis Test Device
Includes: 20 individually packaged devices, 20 disposable sample
droppers, 20 disposable heparinized capillary tubes, 1 dispensing bulb,
1 sample buffer, 1 procedure card, 1 package insert. 20 tests per box
Infectious Mononucleosis
Test Device
For Whole Blood
Serum/Plasma:
Moderately Complex
CPT Code: 86308