FDA product code LDN
Enzymatic Radiochemical Assay, Amikacin
Clinical Toxicology·Class 2·21 CFR 862.3035
US regulatory classifications
- US Product Code (FDA)
- LDNView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.3035View CFR Regulation →
- Medical specialty
- Clinical Toxicology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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About this record
Enzymatic Radiochemical Assay, Amikacin is a medical device type in the Clinical Toxicology 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.