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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, enterovirus nucleic acid
Regulation Description Enterovirus nucleic acid assay.
Definition Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.
Product CodeOAI
Regulation Number 866.3225
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
Cepheid
  GRANTED 1

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