FDA product code GTD: Antisera, Fluorescent, All Globulins, Shigella Spp.
GTD is the FDA product code for antisera, fluorescent, all globulins, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel. Devices under GTD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Globulins, Shigella Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GTD devices
openFDA lists no recalls for product code GTD.
Frequently asked questions
What is FDA product code GTD?
GTD is the FDA product code for antisera, fluorescent, all globulins, shigella spp.. It is a Class II device, regulated under 21 CFR 866.3660 and reviewed by the Microbiology panel.
What device class is GTD?
Class II, regulation 21 CFR 866.3660. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GTD
- Run a recall and safety report across every GTD manufacturer
- Watch product code GTD 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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