Sperm, Antigen, Antiserum, Control
FDA product code DFQ · Class I (low risk) · 21 CFR 866.5800 · Immunology
0510(k) clearances
0PMA approvals
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1263-2026 Class II | Exploro Highly Sensitive Male Fertility / Sperm Concentration TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed… | Changchun Wancheng Bio-Electron Co., Ltd. | 11/22/2025Open, Classified |