FDA product code GSG: Antisera, Fluorescent, All Types, Listeria Monocytogenes
GSG is the FDA product code for antisera, fluorescent, all types, listeria monocytogenes. It is a Class I device, regulated under 21 CFR 866.3355 and reviewed by the Microbiology panel. Devices under GSG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for GSG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, 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 |
Recalls for GSG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code GSG?
GSG is the FDA product code for antisera, fluorescent, 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 GSG?
Class I, regulation 21 CFR 866.3355. Typical premarket route: 510(k) exempt.
Have GSG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code GSG
- Run a recall and safety report across every GSG manufacturer
- Watch product code GSG 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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