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MESOMARK

Fujirebio Diagnostics, Inc. · Model 801-905 · UDI-DI 00869164000000

OAW Prescription
0
510(k) clearances
0
Adverse events
1
Recalls
0
Facilities

Recalls

DateFirmReason
2010-07-29Fujirebio Diagnostics, Inc.presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.

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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.