# Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt
> **Product code: OUS** · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2050
## Classification
- **FDA Product Code:** OUS
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 866.2050
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

The  mrsa/mssa blood  culture test-bt  is a qualitative  ivd test using bacteriophage amplification for the identification of  staphylococcus aureus and the determination of  meca mediated methicillin resistance or methicillin susceptbility  directly  from positive blood cultures  confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OUS)
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