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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device elisa, antibody, west nile virus
Definition The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.
Product CodeNOP
Regulation Number 866.3940
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 1 1

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