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Kit, Rna Detection, Human Papillomavirus

FDA product code OYB · Class 3 · Unknown

9
Registered devices
42
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.

Recent recalls

DateFirmReason
2026-02-18Hologic, Inc.Due to product exhibiting potential to generate either invalid or false negative results.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.