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Found 4 results
510(k) Data Aggregation
K Number
K113371Device Name
STAPHYLOCOCCUS QUICKFISH BC
Manufacturer
ADVANDX, INC.
Date Cleared
2012-04-03
(139 days)
Product Code
NXX
Regulation Number
866.3700Why did this record match?
Product Code :
NXX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth.
Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.
Device Description
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K Number
K092166Device Name
S. AUREUS/CNS PNA FISH, MODEL KT005
Manufacturer
ADVANDX, INC.
Date Cleared
2009-11-23
(125 days)
Product Code
NXX
Regulation Number
866.3700Why did this record match?
Product Code :
NXX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Grampositive cocci in clusters observed on Gram stain.
Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.
Device Description
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K Number
K091827Device Name
S. AUREUS PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2009-08-18
(60 days)
Product Code
NXX
Regulation Number
866.3700Why did this record match?
Product Code :
NXX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
S. aureus PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.
Device Description
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K Number
K060099Device Name
S. AUREUS PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2006-05-08
(115 days)
Product Code
NXX
Regulation Number
866.3700Why did this record match?
Product Code :
NXX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for presumptive identification of Staphylococcus aureus from blood cultures.
Device Description
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