OUS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2050
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT (K120563) | Microphage, Inc. | 2012-03-30 |
| KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT (K102342) | Microphage, Inc. | 2011-05-05 |
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Every clearance here is in the API, with alerts when new ones post.