FDA product code OUZ
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
Microbiology·Class 1·21 CFR 866.3870
US regulatory classifications
- US Product Code (FDA)
- OUZView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 866.3870View CFR Regulation →
- Medical specialty
- Microbiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Detection of Leishmania species in skin lesions.
Search keywords
Click to search for similar devices in our global database
About this record
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids 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.