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OUF — Everolimus Immunoassay Class II

FDA Device Classification

Classification Details

Product Code
OUF
Device Class
Class II
Regulation Number
862.3840
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Definition

To quantify everolimus in whole blood.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K122766microgenicsTHERMO SCIENTIFIC QMS EVEROLIMUS ASSAYAugust 20, 2013
K100144microgenicsTHERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLSFebruary 11, 2011