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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
Regulation Description Herpes simplex virus serological assays.
Product CodeLGC
Regulation Number 866.3305
Device Class 2

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biokit, S.A. II Jan-26-2023
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