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510(k) Data Aggregation
K Number
K093024Device Name
YEAST TRAFFIC LIGHT PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2010-07-15
(289 days)
Product Code
NZS
Regulation Number
866.2660Why did this record match?
Product Code :
NZS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C. parapsilosis. The test does not distinguish between C. qlabrata and C. krusei.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation between C. albicans and C. parapsilosis, differentiation between C. glabrata and C. krusei, and/or differentiation of mixed growth.
Yeast Traffic Light PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia.
Device Description
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K Number
K092784Device Name
C. ALBICANS/C. GLABRATA PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2010-03-12
(183 days)
Product Code
NZS
Regulation Number
866.2660Why did this record match?
Product Code :
NZS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.
Device Description
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K Number
K092655Device Name
C. ALBICANS PNA FISH
Manufacturer
ADVANDX, INC.
Date Cleared
2010-01-19
(144 days)
Product Code
NZS
Regulation Number
866.2660Why did this record match?
Product Code :
NZS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C. albicans PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures.
Subculturing of yeast positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia.
Device Description
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