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U.S. Department of Health and Human Services

Product Classification
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Device interleukin 6
Definition In vitro Diagnostic devices for the quantitative determination of IL-6 (interleukin 6) in human specimens
Physical State In Vitro Diagnostic Device
Technical Method Immunoassay
Target Area The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device.
Review Panel Immunology
Product CodeQLC
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
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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