FDA product code KTN
System, Test, Infectious Mononucleosis
Immunology·Class 2·21 CFR 866.5640
US regulatory classifications
- US Product Code (FDA)
- KTNView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.5640View CFR Regulation →
- Medical specialty
- Immunology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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About this record
System, Test, Infectious Mononucleosis is a medical device type in the Immunology 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.