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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, volatile organic compounds breath analysis
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.
Product CodePAR
Device Class Humanitarian Device Exemption