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MRC | Criteria | Characteristic |
---|---|---|
ALCD | USAGE DESIGN | DETECTION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN URINE OR SERUM |
CKTZ | TEST CAPABILITY QUANTITY | 30 |
CXCY | PART NAME ASSIGNED BY CONTROLLING AGENCY | TEST KIT HCG SERUM/URINE RT 30S |
CYMP | TEST MEDIA | URINE OR SERUM |
CYMS | COMPONENT BREAKDOWN WITHIN EACH TEST KIT | 30 INDIVIDUALLY POUCHED TEST CASSETTES WITH DISPOSABLE PIPETTES |
FEAT | SPECIAL FEATURES | DETECT URINARY HCG CONCENTRATIONS EQUAL TO OR GREATER THAN 20MIU/ML AND SERUM HCG CONCENTRATIONS EQUAL TO OR GREATER THAN 10MIU/ML; ONE-STEP PROCEDURE PROVIDES RESULTS IN 5 MINUTES OR LESS; CLIA WAVED FOR URINE, NONWAIVED FOR SERUM; SPECIFI |
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