FDA product code MBT: Dna-Probe, Reagent, Histoplasma Capsulatum
MBT is the FDA product code for dna-probe, reagent, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MBT. The average 510(k) review took 58 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Dna-Probe, Reagent, Histoplasma Capsulatum |
| Device class | Class II |
| Regulation | 21 CFR 866.3320 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MBT clearance
Top MBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe, Inc. | 1 | 1990-02-01 |
Most recent MBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896859 | Gen-Probe, Inc. | ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST | 1990-02-01 | 58 |
Recalls for MBT devices
openFDA lists no recalls for product code MBT.
Frequently asked questions
What is FDA product code MBT?
MBT is the FDA product code for dna-probe, reagent, histoplasma capsulatum. It is a Class II device, regulated under 21 CFR 866.3320 and reviewed by the Microbiology panel.
What device class is MBT?
Class II, regulation 21 CFR 866.3320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MBT?
Across 1 cleared submissions the average was 58 days from receipt to decision (median 58).
Which companies have the most MBT clearances?
Gen-Probe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MBT
- Run a recall and safety report across every MBT manufacturer
- Watch product code MBT 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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