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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunoabsorbent assay, mumps virus
Regulation Description Mumps virus serological reagents.
Product CodeLJY
Regulation Number 866.3380
Device Class 1

MDR Year MDR Reports MDR Events
2016 5 5
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Break 1 1
Disconnection 1 1
Device Displays Incorrect Message 1 1
Battery Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diamedix Corporation III Jul-28-2018
2 Diamedix Corporation II May-16-2016
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