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U.S. Department of Health and Human Services

Product Classification

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Device sirolimus test system
Regulation Description Sirolimus test system.
Definition Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeNRP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3840
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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