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U.S. Department of Health and Human Services

Product Classification

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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)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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