FDA product code OIE: Urine Collection Kit (Excludes Hiv Testing)

OIE is the FDA product code for 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 OIE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OIE devices.

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 OIE devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-04-17.

Frequently asked questions

What is FDA product code OIE?

OIE is the FDA product code for 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 OIE?

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

Have OIE devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2014-04-17.

Next steps

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