FDA product code MCT: Dna-Probe, Strep Pneumoniae
MCT is the FDA product code for dna-probe, strep pneumoniae. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MCT. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe, Strep Pneumoniae |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MCT clearance
Top MCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 1 | 1990-08-06 |
Most recent MCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902908 | Gen-Probe, Inc. | ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR. | 1990-08-06 | 35 |
Recalls for MCT devices
openFDA lists no recalls for product code MCT.
Frequently asked questions
What is FDA product code MCT?
MCT is the FDA product code for dna-probe, strep pneumoniae. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is MCT?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MCT?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most MCT clearances?
Gen-Probe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MCT
- Run a recall and safety report across every MCT manufacturer
- Watch product code MCT 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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