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Bladder EpiCheck Test Kit

NUCLEIX LTD · Model 02 · UDI-DI 07290019028208

MMW Prescription
1
510(k) clearances
6
Adverse events
1
Recalls
5
Facilities

Recalls

DateFirmReason
2004-02-19VysisSome of the control slides did not have adequate cells deposited upon their surface.

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

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Data 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.