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
Product Specifications:
Part Number
03-0345
Cage Code
89875
NSN Number
6550-01-506-7228 (6550015067228)
NIIN Number
015067228
Item Name
TEST KIT,STREPTOCOCCI GROUP A DE
FSG
65
FSG Name
Medical, Dental, and Veterinary Equipment and Supplies
FSG With Name
65 - Medical, Dental, and Veterinary Equipment and Supplies
FSC
6550
FSC Name
In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
FSC With Name
6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
MFG Name
DEFENSE LOGISTICS AGENCY DIRECTORATE OF MEDICAL MATERIEL DEFENSE SUPPLY CENTER PHILADELPHIA