Mycophenolic Acid Test System
Device Code: 6247
Product Code(s):
OAV 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.
Device Classification Information
| Device Type ID | 6247 |
| Device Name | Mycophenolic Acid Test System |
| Physical State | Liquid |
| Technical Method | Enzyme-mimicking Assay With MPA Concentration Inversely Proportional To The Formation Of NADH. |
| Target Area | Renal And Cardiac Transplant Patients |
| Regulation Description | Sirolimus Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3840 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6247 |
| Device | Mycophenolic Acid Test System |
| Product Code | OAV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sirolimus Test System. |
| CFR Regulation Number | 862.3840 [🔎] |
TPLC Last Update: 2019-04-02 21:19:20