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System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA product code SBB · Class 3 · Unknown

2
Registered devices
0
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

ColoSense Collection Kit — Geneoscopy, Inc.ColoSense Collection Kit — Geneoscopy, Inc.

Recent recalls

DateFirmReason
2025-05-20Geneoscopy, Inc.Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit

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

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