FDA product code MDE: Dna-Probe, Reagents, Cryptococcal
MDE is the FDA product code for dna-probe, reagents, cryptococcal. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MDE. The average 510(k) review took 56 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe, Reagents, Cryptococcal |
| 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 MDE clearance
Top MDE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 1 | 1990-10-02 |
Most recent MDE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903556 | Gen-Probe, Inc. | ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST | 1990-10-02 | 56 |
Recalls for MDE devices
openFDA lists no recalls for product code MDE.
Frequently asked questions
What is FDA product code MDE?
MDE is the FDA product code for dna-probe, reagents, cryptococcal. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.
What device class is MDE?
Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MDE?
Across 1 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most MDE clearances?
Gen-Probe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MDE
- Run a recall and safety report across every MDE manufacturer
- Watch product code MDE 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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