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Apparatus, Automated Blood Cell Diluting

FDA product code GKH · Class 1 · Hematology

7
Registered devices
51
Adverse events
2
Recalls
14
510(k) clearances

Devices with this code

Smart Biopsy™ Isolation Kit — Cytogen, Inc.Smart Biopsy™ Cell Isolator — Cytogen, Inc.Cell Isolator V2 — Cytogen, Inc.CTCeptor — CTCELLS, Inc.CTCD — CTCELLS, Inc.ClearCell® FX1 Unit — BIOLIDICS LIMITEDCTR-S — CTCELLS, Inc.

Recent recalls

DateFirmReason
2010-05-19Veridex, LLCComplaints of patient sample carryover.
2009-05-06Veridex, LLCBottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.

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