NQCHumanitarian device exemption

Test, Breath Analysis, Volatile Organic Compounds

Unknown

NQC is the FDA product code for Test, Breath Analysis, Volatile Organic Compounds. FDA's definition for this code reads: "Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: NQC
Device name: Test, Breath Analysis, Volatile Organic Compounds
FDA definition: Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NQC.

Recent clearances

Product code NQC

FDA records hold no clearances under product code NQC.

Recent recalls

Product code NQC

FDA records show no recalls under product code NQC.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)