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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus
Definition The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).
Product CodeNXX
Regulation Number 866.3700
Device Class 1


Premarket Reviews
ManufacturerDecision
ADVANDX, INC.
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 Advandx Inc II Aug-01-2014
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