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NSN 6550-01-506-8217  ·  NIIN 015068217  ·  FSC 6550
NO DASHES 6550015068217
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TEST KIT,STREPTOCOCCI GROUP A DE

In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

Technical characteristics

4 rows

Straight from the federal item record. Entries the record leaves empty are shown empty — nothing is filled in on its behalf.

Technical characteristics from the federal item record
MRCRequirementValue
ALCDUSAGE DESIGNFOR RAPID DETECTION OF GROUP A STREPTOCOCCAL ANTIGEN DIRECTLY FROM THROAT SWABS AND BETA HEMOLYTIC COLONIES RECOVERED FROM CULTURE
CKTZTEST CAPABILITY QUANTITY25
CYMSCOMPONENT BREAKDOWN WITHIN EACH TEST KITINDIVIDUALLY PACKAGED TEST CASSETTES RABBIT ANTI-STREP A ANTIBODY AND HEAT INACTIVATED STREP A ANTIGEN; EXTRACTION REAGENT A; EXTRACTION REAGENT B; STERILE THROAT SWABS; TUBES AND TIPS, POSITIVE CONTROL; NEGATIVE CONTROL; PACKAGE INSERT, AND PROCEDURE CARD
FEATSPECIAL FEATURESRAPID TEST; CLEARLY DISTINGUISHABLE +/- ENDPOINT AND TWO REAGENT EXTRACTION; 5 MINUTE RESULTS; O/A ACCURACY OF TEST IS 98%/ SENSITIVITY OF 95%, SPECIFICITY 86%; BUILT IN CONTROLS SATISFY CLIA REQUIREMENTS FOR DAILY QC; STORE AT ROOM TEMP; CONTAINS POSITIVE AND NEGATIVE CONTROLS; 25 TESTS