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Alere NMP22 BladderChek Control Kit

Alere Scarborough, Inc. · Model D1250 · UDI-DI 10811877010606

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

Description

The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the Alere NMP22 BladderChek Test.

Recalls

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

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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.