Device type

Blood And Urine Collection Kit (Excludes Hiv Testing)

Product code OIB · Class I · 21 CFR 864.3250 · Pathology

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.

FDA classification database