NRF · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.8625
Classification
FDA Product Code
NRF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.8625
Review panel
HE
Medical specialty
Hematology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.