NXX
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3700
- Medical specialty
- Microbiology
- FDA 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STAPHYLOCOCCUS QUICKFISH BC (K113371) | Advandx, Inc. | 2012-04-03 |
| S. AUREUS/CNS PNA FISH, MODEL KT005 (K092166) | Advandx, Inc. | 2009-11-23 |
| S. AUREUS PNA FISH (K091827) | Advandx, Inc. | 2009-08-18 |
| S. AUREUS PNA FISH (K060099) | Advandx, Inc. | 2006-05-08 |
Track NXX automatically
Every clearance here is in the API, with alerts when new ones post.