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 Code | NXX |
Regulation Number |
866.3700
|
Device Class |
1
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Advandx Inc |
II |
Aug-01-2014 |
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