| COMPONENT BREAKDOWN WITHIN EACH TEST KIT | TEST CASSETTE, POSITVIE CONTROL AND NEGATIVE CONTROL |
| PART NAME ASSIGNED BY CONTROLLING AGENCY | TEST KT HELCOBACTER PYLORI GII QUICKVUE H. PYLORI 10 TESTS |
| PROTECTIVE STORAGE FEATURE | SUBJECT TO DAMAGE BY FREEZING |
| SPECIAL FEATURES | THE QUICKVUE H. PYLORI GII TEST IS A LATERAL-FLOW IMMUNO-CHROMATOGRAPHIC ASSAY INTENDED FOR THE RAPID, QUALITATIVE DETECTION OF IGG ANTIBODIES SPECIFIC TO HELICOBACTER PYLORI IN HUMAN SERUM, PLASMA OR WHOLE BLOOD; IT UTILIZES A CONVENIENT, NON-INVASIVE, AND EASY TO PERFORM TEST METHODOLOGY TO AID PHYSICIANS IN THE DIAGNOSIS OF H.PYLORI; 10 TESTS; POSITIVE AND NEGATIVE CONTROLS INCLUDED; RESULTS IN FIVE MINUTES |
| SUPPLEMENTARY FEATURES | STORE AT ROOM TEMP 59-86 DEG.F |
| TEST CAPABILITY QUANTITY | 10 |
| TOTAL PRIMARY CONTAINER QUANTITY | 10 |
| USAGE DESIGN | QUALITATIVE DETECTION OF LGG ANTIBODIES IN WHOLE BLOOD |