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Material, Quality Control, Semen Analysis

Material, Quality Control, Semen Analysis is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Material, Quality Control, Semen Analysis
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NRF

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Class 2

21 CFR 864.8625

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Hematology

Device Characteristics

No

No

No

Not Eligible

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.