StacksVerified U.S. regulatory reference

21 CFR §862.1620

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
  2. (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.