NRF

Material, Quality Control, Semen Analysis

Product code: NRF
Device name: Material, Quality Control, Semen Analysis
Device class: Class 2
21 CFR: 21 CFR 864.8625
Medical specialty: Hematology
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 3 (all years; only the last 3 years are listed here)

FDA classification definition

A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NRF

Classification and pathway per current FDA publications. Data from openFDA (CC0).