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Automated Colony Counter

FDA product code KZB · Class 1 · Microbiology

1
Registered devices
4
Adverse events
2
Recalls
1
510(k) clearances

Devices with this code

Quebec® Digital Darkfield Colony Counter — REICHERT, INC.

Recent recalls

DateFirmReason
2025-05-06Copan WASPAI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is
2024-07-09Becton Dickinson & Co.There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would imp

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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.