Code of Federal Regulations (Last Updated: February 15, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 884 - Obstetrical and Gynecological Devices |
Subpart B - Obstetrical and Gynecological Diagnostic Devices |
§ 884.1040 - Viscometer for cervical mucus.
Latest version.
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§ 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]