| COMPONENT BREAKDOWN WITHIN EACH TEST KIT | 1 100 TESTS; 2 PACKS; 50 TESTS/PACK |
| FEATURES PROVIDED | ENZYMEIMMUNOASSAY |
| PART NAME ASSIGNED BY CONTROLLING AGENCY | ACCESS AG HBS |
| PROTECTIVE STORAGE FEATURE | REQUIRES REFRIGERATION BETWEEN 2 DEG TO 8 DEG C |
| SPECIAL FEATURES | REQUIRED CALIBRATORS NEGATIVE ANDPOSITIVE FOR HBS AG EVERY 56 DAYS FOR EACH NEW REAGENT PACK; QUALITY CONTROLMATERIALS; SUBSTRATE; WASH BUFFER II |
| TOTAL PRIMARY CONTAINER QUANTITY | 2 |
| USAGE DESIGN | DETECTION OF THE SURFACE ANTIGEN OF THE HEPATITIS B VIRUS IN HUMAN SERUM AND PLASMA |
| TEST CAPABILITY QUANTITY | 100 |
| TEST MEDIA | PLASMA OR SERUM |