NRFClass II
Material, Quality Control, Semen Analysis
21 CFR 864.8625 / Hematology
NRF is the FDA product code for Material, Quality Control, Semen Analysis, a class II device type, regulated under 21 CFR 864.8625. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- NRF
- Device name
- Material, Quality Control, Semen Analysis
- FDA 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.
- Regulation
- 21 CFR 864.8625
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 1
Clearances, product code NRF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2004 | 3 |
Applicants with the most clearances
Product code NRF| Applicant | Clearances |
|---|---|
| Bioscreen, Inc. | 1 |
| Fertility Solutions, Inc. | 1 |
| Medical Electronics Systems, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.