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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, herpes simplex virus, non-specific
Product CodeLGC
Regulation Number 866.3305
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2019 4 4
2020 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioCheck Inc II Mar-11-2011
2 Biokit U.S.A. Inc. II Jul-08-2010
3 Biokit, S.A. II Jan-26-2023
4 Diamedix Corporation III May-10-2012
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