PEO — Fungal Organisms, Nucleic Acid-Based Assay Class II
FDA product code PEO covers "Fungal Organisms, Nucleic Acid-Based Assay", a Class II medical device regulated under 21 CFR 866.3365. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PEO
- Device Class
- Class II
- Regulation Number
- 866.3365
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.