MVJ
6 FDA 510(k) clearances · Product code
67 daysmedian time to decision
218 days90th percentile
6clearances measured
FDA profile
- Official device name
- Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ATHENA MULTI-LYTE GBM TEST SYSTEM (K071219) | Zeus Scientific, Inc. | 2007-12-06 |
| BIOPLEX VASCULITIS KIT (K072358) | Bio-Rad Laboratories | 2007-10-31 |
| PHASE II GBM IGG ANTIBODY EIA TEST (K011348) | Scimedx Corp. | 2001-06-25 |
| AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA (K991890) | Cogent Diagnotics , Ltd. | 1999-08-09 |
| BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (K984619) | The Binding Site, Ltd. | 1999-02-23 |
| QUANTA LITE GBM ELISA (K984336) | Inova Diagnostics, Inc. | 1999-02-08 |
Track MVJ automatically
Every clearance here is in the API, with alerts when new ones post.