FDA Device Intelligence
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Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA product code MYL · Class 3 · Unknown

2
Registered devices
0
Adverse events
3
Recalls
0
510(k) clearances

Devices with this code

LIAISON® Biotrin Parvovirus B19 IgG Plus — DIASORIN SPALIAISON® Biotrin Control Parvovirus B19 IgG Plus — DIASORIN SPA

Recent recalls

DateFirmReason
2023-10-31Zeus Scientific, Inc.The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved
2023-10-31Zeus Scientific, Inc.The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved
2020-07-17Diasorin Inc.Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.