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U.S. Department of Health and Human Services

Product Classification
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Device immunoassay for host biomarkers of infection
Regulation Description Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
Definition A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.
Physical State In vitro diagnostic device
Technical Method Chemiluminescent immunoassay
Target Area Human serum or similar samples
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQPS
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3215
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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