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Material, Quality Control, Semen Analysis
FDA product code NRF · Class 2 · Hematology
33
Registered devices
0
Adverse events
1
Recalls
3
510(k) clearances
Devices with this code
Fertility Solutions — Fertility Solutions, Inc.accu-beads® — HAMILTON THORNE, INC.Fertility Solutions — Fertility Solutions, Inc.LensHooke X QC Reticle (For Semen) — BONRAYBIO CO., LTD.Fertility Solutions — Fertility Solutions, Inc.Sperm-Chex — STRECK, INC.LensHooke X QC Reticle (For Semen) — BONRAYBIO CO., LTD.LensHooke X QC Video (For Semen) — BONRAYBIO CO., LTD.LensHooke X QC Beads (For Semen) — BONRAYBIO CO., LTD.QwikCheck Beads Precision and Linearity kit — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.LensHooke X QC Reticle (For Semen) — BONRAYBIO CO., LTD.LensHooke X QC Slide (For Semen) — BONRAYBIO CO., LTD.LensHooke X QC Slide (For Semen) — BONRAYBIO CO., LTD.Fertility Solutions — Fertility Solutions, Inc.Sperm-Chex Post VC — STRECK, INC.LensHooke X QC Video (For Semen) — BONRAYBIO CO., LTD.LensHooke X QC Video (For Semen) — BONRAYBIO CO., LTD.Fertility Solutions — Fertility Solutions, Inc.QwikCheck Beads — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.Fertility Solutions — Fertility Solutions, Inc.LensHooke X QC Slide (For Semen) — BONRAYBIO CO., LTD.Fertility Solutions — Fertility Solutions, Inc.LensHooke X QC Video (For Semen) — BONRAYBIO CO., LTD.LensHooke X QC Reticle (For Semen) — BONRAYBIO CO., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | 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; |
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