NRF — Material, Quality Control, Semen Analysis Class II
FDA product code NRF covers "Material, Quality Control, Semen Analysis", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NRF
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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.