FDA product code GOS: Antiserum, Fluorescent, C. Diphtheriae
GOS is the FDA product code for antiserum, fluorescent, c. diphtheriae. It is a Class I device, regulated under 21 CFR 866.3140 and reviewed by the Microbiology panel. Devices under GOS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, C. Diphtheriae |
| Device class | Class I |
| Regulation | 21 CFR 866.3140 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GOS devices
openFDA lists no recalls for product code GOS.
Frequently asked questions
What is FDA product code GOS?
GOS is the FDA product code for antiserum, fluorescent, c. diphtheriae. It is a Class I device, regulated under 21 CFR 866.3140 and reviewed by the Microbiology panel.
What device class is GOS?
Class I, regulation 21 CFR 866.3140. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GOS
- Run a recall and safety report across every GOS manufacturer
- Watch product code GOS 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.