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Material, Quality Control, Semen Analysis

FDA product code NRF · 3 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.8625
Review panel
HE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-06-02 – 2004-10-29

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.

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