FDA product code MVJ: Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
MVJ is the FDA product code for devices, measure, antibodies to glomerular basement membrane (gbm). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 6 510(k) submissions under MVJ, from 6 different applicants. The average 510(k) review took 89 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MVJ clearance
Top MVJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 1 | 2007-12-06 |
| Bio-Rad Laboratories | 1 | 2007-10-31 |
| Scimedx Corp. | 1 | 2001-06-25 |
| Cogent Diagnotics , Ltd. | 1 | 1999-08-09 |
| The Binding Site, Ltd. | 1 | 1999-02-23 |
1 more applicants have MVJ clearances. See the full list in Caduvo.
Most recent MVJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071219 | Zeus Scientific, Inc. | ATHENA MULTI-LYTE GBM TEST SYSTEM | 2007-12-06 | 218 |
| K072358 | Bio-Rad Laboratories | BIOPLEX VASCULITIS KIT | 2007-10-31 | 70 |
| K011348 | Scimedx Corp. | PHASE II GBM IGG ANTIBODY EIA TEST | 2001-06-25 | 54 |
| K991890 | Cogent Diagnotics , Ltd. | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | 1999-08-09 | 67 |
| K984619 | The Binding Site, Ltd. | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | 1999-02-23 | 56 |
Recalls for MVJ devices
openFDA lists no recalls for product code MVJ.
Frequently asked questions
What is FDA product code MVJ?
MVJ is the FDA product code for devices, measure, antibodies to glomerular basement membrane (gbm). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is MVJ?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVJ?
Across 6 cleared submissions the average was 89 days from receipt to decision (median 67).
Which companies have the most MVJ clearances?
Zeus Scientific, Inc. (1); Bio-Rad Laboratories (1); Scimedx Corp. (1); Cogent Diagnotics , Ltd. (1); The Binding Site, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MVJ
- Run a recall and safety report across every MVJ manufacturer
- Watch product code MVJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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