Test, Volatile Organic Compounds Breath Analysis

PAR · f · Unknown

Classification

FDA Product Code: PAR
Device class: f
Regulation: —
Review panel: CH
Medical specialty: Unknown
Submission type: 6
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown