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LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
BONRAYBIO CO., LTD. · Model R11 Plus-01 Package-10 tests-US-HT · UDI-DI 14719874743533
POV
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
15
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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Get your free API keyRead the docsData 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.