Product code NQC

Device name

Test, Breath Analysis, Volatile Organic Compounds

Medical specialty

Unknown

Device class

f

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset