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U.S. Department of Health and Human Services

Product Classification
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Device antigen, inflammatory response marker, sepsis
Regulation Description Endotoxin assay.
Definition An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNTM
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3210
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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