FDA product code GTB: Antisera, Fluorescent, All Types, Klebsiella Spp.
GTB is the FDA product code for antisera, fluorescent, all types, klebsiella spp.. It is a Class I device, regulated under 21 CFR 866.3340 and reviewed by the Microbiology panel. Devices under GTB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Types, Klebsiella Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3340 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GTB devices
openFDA lists no recalls for product code GTB.
Frequently asked questions
What is FDA product code GTB?
GTB is the FDA product code for antisera, fluorescent, all types, klebsiella spp.. It is a Class I device, regulated under 21 CFR 866.3340 and reviewed by the Microbiology panel.
What device class is GTB?
Class I, regulation 21 CFR 866.3340. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GTB
- Run a recall and safety report across every GTB manufacturer
- Watch product code GTB 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.