Product code
NXX: Fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus
FDA product code · Class I · Microbiology
Key facts
| Product code | NXX |
|---|---|
| Device | Fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus |
| Device class | Class I |
| Regulation number | 866.3700 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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). |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database