FDA product code GTL: Phages, Staphylococcal Typing, All Types
GTL is the FDA product code for phages, staphylococcal typing, all types. It is a Class I device, regulated under 21 CFR 866.2050 and reviewed by the Microbiology panel. Devices under GTL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Phages, Staphylococcal Typing, All Types |
| Device class | Class I |
| Regulation | 21 CFR 866.2050 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GTL devices
openFDA lists no recalls for product code GTL.
Frequently asked questions
What is FDA product code GTL?
GTL is the FDA product code for phages, staphylococcal typing, all types. It is a Class I device, regulated under 21 CFR 866.2050 and reviewed by the Microbiology panel.
What device class is GTL?
Class I, regulation 21 CFR 866.2050. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GTL
- Run a recall and safety report across every GTL manufacturer
- Watch product code GTL 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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