# Material, Quality Control, Semen Analysis
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NRF)
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