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510(k) Data Aggregation
K Number
K090964Device Name
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
Manufacturer
BINAX, INC.
Date Cleared
2009-12-16
(254 days)
Product Code
JWX
Regulation Number
866.2660Why did this record match?
Product Code :
JWX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
Device Description
The BinaxNOW" Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sensitive polyclonal antibodies to detect a Staphylococcus aureus specific protein directly from blood cultures which have been identified as being positive for Gram-positive cocci in clusters. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device. Specimens are aliquots from blood cultures which have been identified as positive for Gram-positive cocci in clusters. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.
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K Number
K972030Device Name
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
Manufacturer
OXOID, LTD.
Date Cleared
1997-09-08
(98 days)
Product Code
JWX
Regulation Number
866.2660Why did this record match?
Product Code :
JWX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
Device Description
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests.
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K Number
K964315Device Name
REMEL STAPH LATEX KIT
Manufacturer
REMEL, L.P.
Date Cleared
1997-02-07
(101 days)
Product Code
JWX
Regulation Number
866.2660Why did this record match?
Product Code :
JWX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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