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510(k) Data Aggregation
K Number
K080719Device Name
YEAST TRAFFIC LIGHT PNA FISH
Manufacturer
Date Cleared
2008-09-12
(183 days)
Product Code
Regulation Number
866.2660Why did this record match?
Product Code :
JXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 from positive blood cultures. The test does not distinguish between C. glabrata and C. krusei. The test does not distinguish between C. albicans and C. parapsilosis.
Device Description
Not Found
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K Number
K062461Device Name
C. ALBICANS PNA FISH
Manufacturer
Date Cleared
2006-10-25
(63 days)
Regulation Number
866.2660Why did this record match?
Product Code :
JXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
C. albicans PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures.
Device Description
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K Number
K993554Device Name
YEASTEST
Manufacturer
Date Cleared
2000-02-10
(113 days)
Product Code
Regulation Number
866.2660Why did this record match?
Product Code :
JXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.
Device Description
Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit
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