FDA product code GSI: Antigens, Slide And Tube, All Types, Listeria Monocytogenes
GSI is the FDA product code for antigens, slide and tube, all types, listeria monocytogenes. It is a Class I device, regulated under 21 CFR 866.3355 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GSI. The average 510(k) review took 46 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Slide And Tube, All Types, Listeria Monocytogenes |
| Device class | Class I |
| Regulation | 21 CFR 866.3355 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GSI clearance
Top GSI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scientific Device Laboratory, Inc. | 1 | 1984-03-23 |
Most recent GSI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K840503 | Scientific Device Laboratory, Inc. | SDL LISTERIA MONOCYTOGENES CONTROL | 1984-03-23 | 46 |
Recalls for GSI devices
openFDA lists no recalls for product code GSI.
Frequently asked questions
What is FDA product code GSI?
GSI is the FDA product code for antigens, slide and tube, all types, listeria monocytogenes. It is a Class I device, regulated under 21 CFR 866.3355 and reviewed by the Microbiology panel.
What device class is GSI?
Class I, regulation 21 CFR 866.3355. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSI?
Across 1 cleared submissions the average was 46 days from receipt to decision (median 46).
Which companies have the most GSI clearances?
Scientific Device Laboratory, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GSI
- Run a recall and safety report across every GSI manufacturer
- Watch product code GSI 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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