# Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
> **Product code: OAH** · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3740
## Classification
- **FDA Product Code:** OAH
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 866.3740
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.

## 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=OAH)
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