FDA product code OIA: Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)
OIA is the FDA product code for neonatal blood collection kit and screening form (excludes hiv testing). It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Clinical Chemistry panel. Devices under OIA 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 | Neonatal Blood Collection Kit And Screening Form (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 OIA devices
openFDA lists no recalls for product code OIA.
Frequently asked questions
What is FDA product code OIA?
OIA is the FDA product code for neonatal blood collection kit and screening form (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 OIA?
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 OIA
- Run a recall and safety report across every OIA manufacturer
- Watch product code OIA 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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