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U.S. Department of Health and Human Services

Product Classification

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Device everolimus immunoassay
Regulation Description Sirolimus test system.
Definition To quantify everolimus in whole blood.
Physical State NA
Technical Method immunoassay
Target Area IVD
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeOUF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3840
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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