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Found 4 results
510(k) Data Aggregation
K Number
K121991Device Name
ENTEROCOCCUS QUICKFISH BC
Manufacturer
ADVANDX, INC.
Date Cleared
2013-01-07
(185 days)
Product Code
OAH
Regulation Number
866.3740Why did this record match?
Product Code :
OAH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing grampositive cocci in pairs and chains observed on Gram stain.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.
Device Description
Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay
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K Number
K083074Device Name
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
Manufacturer
ADVANDX, INC.
Date Cleared
2009-07-24
(282 days)
Product Code
OAH
Regulation Number
866.3740Why did this record match?
Product Code :
OAH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
E. faecalis/OE PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and the detection of selected other enterococci (OE) on smears made from positive blood cultures containing Grampositive cocci in pairs and chains observed on Gram stain.
Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
Device Description
Not Found
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K Number
K082612Device Name
GBS PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2009-05-05
(238 days)
Product Code
OAH
Regulation Number
866.3740Why did this record match?
Product Code :
OAH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K063127Device Name
ENTEROCOCCUS FAECALIS PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2006-12-22
(70 days)
Product Code
OAH
Regulation Number
866.3740Why did this record match?
Product Code :
OAH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
E. faecalis PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures.
Device Description
Not Found
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