Part No. : 20108 | Manufacturer : quidel corporation | CAGE Code : 0TH42 |
NSN : 6550-01-506-7228 | Item Name : test kit streptococci group a de |
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MRC | Criteria | Characteristic |
---|---|---|
AGAV | End Item Identification | INTENDED FOR RAPID QUALITATIVE DETECTION OF GROUP A STREPTOCOCCAL ANTIGEN FROM THROAT SWABS OR CONFIRMATION OF PRESUMPTIVE GROUP A STREPTOCOCCAL COLONIES RECOVERED FROM CULTURE; CLIA WAIVED |
SUPP | Supplementary Features | CLIA WAIVED |
MRC | Decoded Requirement | Clear Text Reply |
FEAT | Special Features | LATERAL FLOW METHOD; ACCURACY AT 95%, READ RESULTS AT 5 MINUTES; SENSITIVITY: 92%, SPECIFICITY: 98%, SPECIMEN TYPE: THROAT SWAB; POSITIVE AND NEGATIVE INTERNAL PROCEDURE CONTROLS; POSITIVE AND NEGATIVE LIQUID EXTERNAL CONTROLS; STORE AT ROOM TEMP; DIPSTICK FORMAT; NO INSTRUMENTATION NEEDED; ALL EQUIPMENT TO PERFORM 50 TESTS INCLUDED |
ALCD | Usage Design | FOR RAPID QUALITATIVE DETECTION OF GROUP A STREPTOCOCCAL ANTIGEN FROM THROAT SWABS OR CONFIRMATION OF PRESUMPTIVE GROUP A STREPTOCOCCAL COLONIES RECOVERED FROM CULTURE |
CXCY | Part Name Assigned By Controlling Agency | QUICKVUE DIPSTICK STREP A TEST;50S |
CKTZ | Test Capability Quantity | 50 |
CYMS | Component Breakdown Within Each Test Kit | TESTRIP, POSITIVE CONTROL SOLUTION, NEGATIVE CONTROL SOLUTION, EXTRACTION SOLUTION A, EXTRACTION SOLUTION B |
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