OAV — Mycophenolic Acid Test System Class II
FDA product code OAV covers "Mycophenolic Acid Test System", a Class II medical device regulated under 21 CFR 862.3840. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAV
- Device Class
- Class II
- Regulation Number
- 862.3840
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K102772 | siemens heatlhcare diagnostics | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLI | October 7, 2011 |
| K081083 | thermo fisher scientific | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS | December 19, 2008 |
| K063520 | roche diagnostics | ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS | February 16, 2007 |