FDA product code OSU: Dengue Serological Reagents
OSU is the FDA product code for dengue serological reagents. It is a Class II device, regulated under 21 CFR 866.3945 and reviewed by the Microbiology panel. Devices under OSU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Dengue Serological Reagents |
| Device class | Class II |
| Regulation | 21 CFR 866.3945 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for OSU devices
openFDA lists no recalls for product code OSU.
Frequently asked questions
What is FDA product code OSU?
OSU is the FDA product code for dengue serological reagents. It is a Class II device, regulated under 21 CFR 866.3945 and reviewed by the Microbiology panel.
What device class is OSU?
Class II, regulation 21 CFR 866.3945. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OSU
- Run a recall and safety report across every OSU manufacturer
- Watch product code OSU 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.