§884.1040. Viscometer for cervical mucus.
21 C.F.R. § 884.1040
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.
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.
Notes, amendments, and revision history
Amendments
[47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.
Amendments
[47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000]