NQC — Test, Breath Analysis, Volatile Organic Compounds Class f

FDA Device Classification

FDA product code NQC covers "Test, Breath Analysis, Volatile Organic Compounds", a Class f medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
NQC
Device Class
Class f
Regulation Number
Submission Type
Review Panel
CH
Medical Specialty
Unknown
Implant
No

Definition

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