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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State in vitro diagnostic reagent kit
Technical Method enzyme linked immunosorbent assay (ELISA)
Target Area in vitro diagnostic for use with serum and plasma
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOSX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1117
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible