PEO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fungal Organisms, Nucleic Acid-Based Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Medical specialty
- Microbiology
- FDA definition
- A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIAISON PLEX Yeast Blood Culture Assay (K240627) | Luminex Corporation | 2024-06-04 |
| ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (K182690) | Genmark Diagnostics, Incorporated | 2018-12-21 |
Track PEO automatically
Every clearance here is in the API, with alerts when new ones post.