DeviceClearance

Product code NRF— Hematology

QC-BEADS

Classification name
Material, Quality Control, Semen Analysis
Device class
Class 2
Regulation
21 CFR 864.8625
Advisory panel
Hematology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NRF under 21 CFR 864.8625, via openFDA

Market context for product code NRF

FDA has cleared 3 devices under product code NRF, all in 2004, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NRF

Recent clearances under product code NRF

Data sourced from openFDA. This site is unofficial and independent of the FDA.