FDA product code OIB: Blood And Urine Collection Kit (Excludes Hiv Testing)

OIB is the FDA product code for blood and urine collection 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 OIB reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 29 recalls for OIB devices, 26 initiated in the last five years.

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

Recalls for OIB devices

29 product recalls in 19 recall events; 26 initiated in the last five years and 26 still open. Most recent: 2026-08-11.

Frequently asked questions

What is FDA product code OIB?

OIB is the FDA product code for blood and urine collection 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 OIB?

Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.

Have OIB devices been recalled?

Yes: 29 product recalls across 19 recall events; the most recent began 2026-08-11.

Next steps

• Run an FDA pathway report with predicate devices for product code OIB
• Run a recall and safety report across every OIB manufacturer
• Watch product code OIB 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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