MRC | Criteria | Characteristic |
---|---|---|
CBBL | FEATURES PROVIDED | ENZYMEIMMUNOASSAY |
CXCY | PART NAME ASSIGNED BY CONTROLLING AGENCY | ACCESS AB HBS II |
ALCD | USAGE DESIGN | FOR DETERMINATION OF ANTIBODY LEVELS TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND PLASMA |
CSCW | TOTAL PRIMARY CONTAINER QUANTITY | 2 |
CKTZ | TEST CAPABILITY QUANTITY | 100 |
CTSF | PROTECTIVE STORAGE FEATURE | REQUIRES REFRIGERATION BETWEEN 2 DEG TO 8 DEG C |
CYMP | TEST MEDIA | PLASMA OR SERUM |
FEAT | SPECIAL FEATURES | REQUIRED ACTIVE CALIBRATION CURVEPROVIDED AT ZERO AND APPROXIMATELY 10,20,50,250 AND 750 MIU/ML EVERY 56 DAYSFOR THE ACCESS HBS AB ASSAY; QUALITY CONTROL MATERIALS; SUBSTRATE; WASH BUFFER II |
CYMS | COMPONENT BREAKDOWN WITHIN EACH TEST KIT | 1 100 DETERMINATIONS; 2 PACKS; 50TESTS/PACK |
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