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Semen Analysis Device

FDA product code POV · 28 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.5220
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1989-02-15 – 2026-04-09

Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.

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