Title 21

SECTION 884.1040

884.1040 Viscometer for cervical mucus.

§ 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.

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