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TPLC - Total Product Life Cycle

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Device mycoplasma pneumoniae dna assay system
Regulation Description Respiratory viral panel multiplex nucleic acid assay.
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


Premarket Reviews
ManufacturerDecision
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

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