FDA product code DID: Bacillus Subtilis Microbiology Assay, Tobramycin
DID is the FDA product code for bacillus subtilis microbiology assay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under DID, from 5 different applicants. The average 510(k) review took 32 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Bacillus Subtilis Microbiology Assay, Tobramycin |
| Device class | Class II |
| Regulation | 21 CFR 862.3900 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DID clearance
Top DID applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1982-04-08 |
| Beckman Instruments, Inc. | 1 | 1980-10-23 |
| Monitor Science Corp. | 1 | 1978-08-14 |
| New England Nuclear | 1 | 1978-02-13 |
| Nichols Institute Diagnostics | 1 | 1978-01-20 |
Most recent DID clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820773 | Syva Co. | EMIT-ST URINE COCAINE METABOLITE ASSAY | 1982-04-08 | 16 |
| K802038 | Beckman Instruments, Inc. | PHENYTOIN REAGENT TEST KIT | 1980-10-23 | 59 |
| K780950 | Monitor Science Corp. | BIO-MONITOR TOBRAMYCIN | 1978-08-14 | 66 |
| K780182 | New England Nuclear | TOBRAMYCIN 125I RIA KIT | 1978-02-13 | 10 |
| K780048 | Nichols Institute Diagnostics | AMINOGLYCOSIDE TEST SYSTEM | 1978-01-20 | 11 |
Recalls for DID devices
openFDA lists no recalls for product code DID.
Frequently asked questions
What is FDA product code DID?
DID is the FDA product code for bacillus subtilis microbiology assay, tobramycin. It is a Class II device, regulated under 21 CFR 862.3900 and reviewed by the Clinical Toxicology panel.
What device class is DID?
Class II, regulation 21 CFR 862.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code DID?
Across 5 cleared submissions the average was 32 days from receipt to decision (median 16).
Which companies have the most DID clearances?
Syva Co. (1); Beckman Instruments, Inc. (1); Monitor Science Corp. (1); New England Nuclear (1); Nichols Institute Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DID
- Run a recall and safety report across every DID manufacturer
- Watch product code DID 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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