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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device meningitis/encephalitis pathogen multiplex nucleic acid detection system
Definition A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.
Product CodePLO
Regulation Number 866.3970
Device Class 2

Premarket Reviews

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 4 4
False Positive Result 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 3 3
Coma 1 1
No Information 1 1

Manufacturer Recall Class Date Posted
1 DiaSorin Molecular LLC II Jul-10-2020