FDA product code MDU: Antigen, Elisa, Cryptococcus
MDU is the FDA product code for antigen, elisa, cryptococcus. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MDU, from 2 different applicants. The average 510(k) review took 192 days (median 192). FDA has posted 1 recall for MDU devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Elisa, Cryptococcus |
| Device class | Class II |
| Regulation | 21 CFR 866.3165 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MDU clearance
Top MDU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno-Mycologics, Inc. | 1 | 2012-12-17 |
| Meridian Diagnostics, Inc. | 1 | 1991-01-25 |
Most recent MDU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120946 | Immuno-Mycologics, Inc. | ALPHA CRYPTOCOCCAL ANTIGEN EIA | 2012-12-17 | 263 |
| K904393 | Meridian Diagnostics, Inc. | PREMIER-CRYPTOCOCCAL ANTIGEN | 1991-01-25 | 122 |
Recalls for MDU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-17.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code MDU?
MDU is the FDA product code for antigen, elisa, cryptococcus. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.
What device class is MDU?
Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MDU?
Across 2 cleared submissions the average was 192 days from receipt to decision (median 192).
Which companies have the most MDU clearances?
Immuno-Mycologics, Inc. (1); Meridian Diagnostics, Inc. (1).
Have MDU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-12-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MDU
- Run a recall and safety report across every MDU manufacturer
- Watch product code MDU 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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