Everolimus Immunoassay
The Everolimus Immunoassay (product code OUF) is an in vitro diagnostic test used to quantify everolimus concentrations in whole blood. Everolimus is an immunosuppressant used in transplant patients and cancer therapy, and therapeutic drug monitoring via this assay helps ensure appropriate dosing. As an FDA Class 2 device under regulation 862.3840, it requires 510(k) premarket clearance and falls within the Clinical Toxicology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OUF
- Device Class
- FDA class 2
- Regulation Number
- 862.3840
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
To quantify everolimus in whole blood.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.