FDA product code OZB: Dengue Nucleic Acid Amplification Assay (Naat)
OZB is the FDA product code for dengue nucleic acid amplification assay (naat). It is a Class II device, regulated under 21 CFR 866.3946 and reviewed by the Microbiology panel. Devices under OZB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).
Classification
| Field | Value |
|---|---|
| Device name | Dengue Nucleic Acid Amplification Assay (Naat) |
| Device class | Class II |
| Regulation | 21 CFR 866.3946 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for OZB devices
openFDA lists no recalls for product code OZB.
Frequently asked questions
What is FDA product code OZB?
OZB is the FDA product code for dengue nucleic acid amplification assay (naat). It is a Class II device, regulated under 21 CFR 866.3946 and reviewed by the Microbiology panel.
What device class is OZB?
Class II, regulation 21 CFR 866.3946. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OZB
- Run a recall and safety report across every OZB manufacturer
- Watch product code OZB 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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