21 C.F.R. § 884.1040

Current through September 30, 2024
Section 884.1040 - Viscometer for cervical mucus
(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 .

21 C.F.R. §884.1040

47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000