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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chlamydophila pneumoniae dna assay system
Regulation Description Respiratory viral panel multiplex nucleic acid assay.
Definition A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Product CodeOZY
Regulation Number 866.3980
Device Class 2

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