FDA product code MVS: Kit, Typing, Hla-Dqb
MVS is the FDA product code for kit, typing, hla-dqb. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under MVS. The average 510(k) review took 46 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Typing, Hla-Dqb |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | HE — Hematology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MVS clearance
Top MVS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cheshire Diagnostics , Ltd. | 1 | 2002-04-19 |
Most recent MVS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020694 | Cheshire Diagnostics , Ltd. | QAB2A IGM ELISA KIT | 2002-04-19 | 46 |
Recalls for MVS devices
openFDA lists no recalls for product code MVS.
Frequently asked questions
What is FDA product code MVS?
MVS is the FDA product code for kit, typing, hla-dqb. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Hematology panel.
What device class is MVS?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVS?
Across 1 cleared submissions the average was 46 days from receipt to decision (median 46).
Which companies have the most MVS clearances?
Cheshire Diagnostics , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MVS
- Run a recall and safety report across every MVS manufacturer
- Watch product code MVS 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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