PGV
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anti-Phospholipase A2 Receptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5780
- Medical specialty
- Microbiology
- Flags
- Life-sustaining · Third-party review eligible
- FDA definition
- The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EUROIMMUN ANTI-PLA2R ELISA (IGG) (K132195) | Euroimmun Us, Inc. | 2014-06-27 |
| EUROIMMUN ANTI-PLA2R IFA (DEN140002) | Euroimmun US | 2014-05-29 |
Track PGV automatically
Every clearance here is in the API, with alerts when new ones post.