FDA product code QBG: Assay, Oral Direct Thrombin Inhibitor
QBG is the FDA product code for assay, oral direct thrombin inhibitor. It is a Not classified device, reviewed by the Hematology panel. Devices under QBG reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma
Classification
| Field | Value |
|---|---|
| Device name | Assay, Oral Direct Thrombin Inhibitor |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QBG devices
openFDA lists no recalls for product code QBG.
Frequently asked questions
What is FDA product code QBG?
QBG is the FDA product code for assay, oral direct thrombin inhibitor. It is a Not classified device, reviewed by the Hematology panel.
What device class is QBG?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QBG
- Run a recall and safety report across every QBG manufacturer
- Watch product code QBG 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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