FDA product code OZY: Chlamydophila Pneumoniae Dna Assay System
OZY is the FDA product code for chlamydophila pneumoniae dna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. Devices under OZY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Classification
| Field | Value |
|---|---|
| Device name | Chlamydophila Pneumoniae Dna Assay System |
| Device class | Class II |
| Regulation | 21 CFR 866.3980 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for OZY devices
openFDA lists no recalls for product code OZY.
Frequently asked questions
What is FDA product code OZY?
OZY is the FDA product code for chlamydophila pneumoniae dna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OZY?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OZY
- Run a recall and safety report across every OZY manufacturer
- Watch product code OZY 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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