FDA product code PEO
Fungal Organisms, Nucleic Acid-Based Assay
Microbiology·Class 2·21 CFR 866.3365
US regulatory classifications
- US Product Code (FDA)
- PEOView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.3365View CFR Regulation →
- Medical specialty
- Microbiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
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About this record
Fungal Organisms, Nucleic Acid-Based Assay is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.