• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device test, breath analysis, volatile organic compounds
Definition Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients
Review Panel Clinical Chemistry
Product CodeNQC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-