NRFClass II

Material, Quality Control, Semen Analysis

Hematology · 21 CFR 864.8625

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.

MDR events0All time

Recalls1All time

Registered firms12Currently listed

510(k) clearances3All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Changchun Wancheng Bio-Electron Co., Ltd.
Open, ClassifiedFeb 4, 2026
Male Fertility Sperm Test for Home Use (Cassette)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Z-1262-2026 · View FDA record ↗

Registered firms

12 firms currently registered for this product code

510(k) clearances

3 clearances for this product code