← FDA Medical Device Classifications
Test, Breath Analysis, Volatile Organic Compounds
NQC · f · Unknown
Classification
- FDA Product Code
NQC- 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
Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown