21 CFR § 862.1385 - 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
(a) Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
The following state regulations pages link to this page.