Electronic Code of Federal Regulations
We invite you to try out our new beta eCFR site at
https://ecfr.federalregister.gov. We have made big
changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom
right of each page!
|
e-CFR data is current as of April 9, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1605 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1605 Pregnanediol test system.
(a) Identification. A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
(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.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]