FDA product code SGD: Kit D816v Mutation Detection System
SGD is the FDA product code for kit d816v mutation detection system. It is a HDE device, reviewed by the Pathology panel. Devices under SGD reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
A KIT D816V mutation detection system is an in vitro diagnostic test intended for qualitative detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis using nucleic acid amplification and real time detection systems. The KIT D816V mutation detection system is indicated as an aid in the selection of aggressive systemic mastocytosis patients for whom Gleevec® (imatinib mesylate) treatment is being considered.
Classification
| Field | Value |
|---|---|
| Device name | Kit D816v Mutation Detection System |
| Device class | HDE |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for SGD devices
openFDA lists no recalls for product code SGD.
Frequently asked questions
What is FDA product code SGD?
SGD is the FDA product code for kit d816v mutation detection system. It is a HDE device, reviewed by the Pathology panel.
What device class is SGD?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code SGD
- Run a recall and safety report across every SGD manufacturer
- Watch product code SGD 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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