FDA product code MDC: Dna-Probe - Blastomyces Dermatitidis
MDC is the FDA product code for dna-probe - blastomyces dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MDC. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe - Blastomyces Dermatitidis |
| Device class | Class II |
| Regulation | 21 CFR 866.3060 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MDC clearance
Top MDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 1 | 1990-09-12 |
Most recent MDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903201 | Gen-Probe, Inc. | ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST | 1990-09-12 | 54 |
Recalls for MDC devices
openFDA lists no recalls for product code MDC.
Frequently asked questions
What is FDA product code MDC?
MDC is the FDA product code for dna-probe - blastomyces dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel.
What device class is MDC?
Class II, regulation 21 CFR 866.3060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MDC?
Across 1 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most MDC clearances?
Gen-Probe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MDC
- Run a recall and safety report across every MDC manufacturer
- Watch product code MDC 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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