PAR

Test, Volatile Organic Compounds Breath Analysis

Product code: PAR
Device name: Test, Volatile Organic Compounds Breath Analysis
Device class: Class F
Medical specialty: Unknown
Marketing pathway: HDE - Humanitarian Device Exemption

FDA classification definition

Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PAR

Classification and pathway per current FDA publications. Data from openFDA (CC0).