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LensHooke X QC Reticle (For Semen)

BONRAYBIO CO., LTD. · Model X QC Reticle - L0_BR USA CORP. · UDI-DI 04719874740887

NRF
3
510(k) clearances
0
Adverse events
1
Recalls
11
Facilities

Recalls

DateFirmReason
2025-11-22Changchun 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; devices may cause fa

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.