Home › Device types › MYM
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
| Date | Firm | Reason |
|---|---|---|
| 2019-08-12 | Zeus 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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