OIE

Urine Collection Kit (Excludes Hiv Testing)

Product code

OIE

Device name

Urine Collection Kit (Excludes Hiv Testing)

Device class

Class 1

21 CFR

21 CFR 864.3250

Medical specialty

Pathology

Marketing pathway

Enforcement Discretion

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).