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U.S. Department of Health and Human Services

Product Classification
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Device st2 assay
Regulation Description B-type natriuretic peptide test system.
Definition Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
Physical State test reagents
Technical Method Quantitative sandwich monoclonal ELISA
Target Area In Vitro Diagnostics
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOYG
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1117
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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