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Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA product code MYM · Class 3 · Unknown

0
Registered devices
0
Adverse events
1
Recalls
0
510(k) clearances

Recent recalls

DateFirmReason
2019-08-12Zeus Scientific, Inc.FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor

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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.