FDA product code OHZ: Urine Transport Kit (Excludes Hiv Testing)
OHZ is the FDA product code for urine transport kit (excludes hiv testing). It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Clinical Chemistry panel. Devices under OHZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Urine Transport Kit (Excludes Hiv Testing) |
| Device class | Class I |
| Regulation | 21 CFR 864.3250 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Recalls for OHZ devices
openFDA lists no recalls for product code OHZ.
Frequently asked questions
What is FDA product code OHZ?
OHZ is the FDA product code for urine transport kit (excludes hiv testing). It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Clinical Chemistry panel.
What device class is OHZ?
Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OHZ
- Run a recall and safety report across every OHZ manufacturer
- Watch product code OHZ 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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