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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device galectin-3 in vitro diagnostic assay
Regulation Description B-type natriuretic peptide test system.
Definition Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
Product CodeOSX
Regulation Number 862.1117
Device Class 2

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