Pure Global AI
FDA product code NQC

Test, Breath Analysis, Volatile Organic Compounds

UnknownClass f21 CFR
US regulatory classifications
US Product Code (FDA)
NQC
US Risk Class (FDA)
Class f
US Regulation (CFR)
21 CFR
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients

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About this record

Test, Breath Analysis, Volatile Organic Compounds is a medical device type in the Unknown 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.