# Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
> **Product code: NXX** · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3700
## Classification
- **FDA Product Code:** NXX
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 866.3700
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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).

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NXX)
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