OAV
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mycophenolic Acid Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3840
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) (K102772) | Siemens Heatlhcare Diagnostics, Inc. | 2011-10-07 | + Add |
| CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS (K081083) | Thermo Fisher Scientific | 2008-12-19 | + Add |
| ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS (K063520) | Roche Diagnostics | 2007-02-16 | + Add |
Track OAV automatically
Every clearance here is in the API, with alerts when new ones post.