Material, Quality Control, Semen Analysis

What Is It?

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.

How Is NRF Classified?

Material, Quality Control, Semen Analysis is FDA product code NRF, Class 2, 21 CFR 864.8625.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2025. 1 was by a company in China. The root cause the FDA records most often is No Marketing Application (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.