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TPLC - Total Product Life Cycle

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Device mycoplasma pneumoniae dna assay system
Definition A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Product CodeOZX
Regulation Number 866.3980
Device Class 2