NSN 6550-01-506-7228 · NIIN 015067228 · FSC 6550
NO DASHES 6550015067228
In Stock
TEST KIT,STREPTOCOCCI GROUP A DE
In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
Application: 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
Technical characteristics
7 rows
Straight from the federal item record. Entries the record leaves empty are shown empty — nothing is filled in on its behalf.
| MRC | Requirement | Value |
|---|---|---|
| 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 |
| 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 |
| CKTZ | TEST CAPABILITY QUANTITY | 50 |
| CXCY | PART NAME ASSIGNED BY CONTROLLING AGENCY | QUICKVUE DIPSTICK STREP A TEST;50S |
| CYMS | COMPONENT BREAKDOWN WITHIN EACH TEST KIT | TESTRIP, POSITIVE CONTROL SOLUTION, NEGATIVE CONTROL SOLUTION, EXTRACTION SOLUTION A, EXTRACTION SOLUTION B |
| 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 |
| SUPP | SUPPLEMENTARY FEATURES | CLIA WAIVED |