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U.S. Department of Health and Human Services

Product Classification
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Device chemiluminescent immunoassay system
Definition For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.
Physical State n/a
Technical Method Chemiluminescent immunoassay
Target Area In vitro
Review Panel Toxicology
Product CodePKM
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
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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