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Kit, Serological, Positive Control

FDA product code MJX · Class 1 · Clinical Chemistry

9
Registered devices
2
Adverse events
1
Recalls
7
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2016-06-22Ortho-Clinical DiagnosticsThe signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negativ

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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.