21 C.F.R. § 884.1040 Viscometer for cervical mucus.
Title 21 - Food and Drugs
(a) Identification. A viscometer for cervical mucus is a device that is intended to measure the relative viscoelasticity of cervical mucus collected from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluation of a female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm. (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 §884.9. [47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart B—Obstetrical and Gynecological Diagnostic Devices
§ 884.1040 Viscometer for cervical mucus.
