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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device enzyme linked immunosorbent assay, herpes simplex virus, hsv-1
Regulation Description Herpes simplex virus serological assays.
Product CodeMXJ
Regulation Number 866.3305
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOKIT, S.A.
  SUBSTANTIALLY EQUIVALENT 1
THERANOS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 4 4
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

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