FDA product code OID: Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)

OID is the FDA product code for sex crimes / sexual assault / suspect evidence collection kit (excludes hiv testing). It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Clinical Chemistry panel. Devices under OID 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

Recalls for OID devices

openFDA lists no recalls for product code OID.

Frequently asked questions

What is FDA product code OID?

OID is the FDA product code for sex crimes / sexual assault / suspect evidence collection kit (excludes hiv testing). It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Clinical Chemistry panel.

What device class is OID?

Class I, regulation 21 CFR 866.2900. Typical premarket route: 510(k) exempt.

Next steps

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