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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Mycoplasma pneumoniae DNA detection assay systems are devices that consist of reagents and instruments for the detection of Mycoplasma pneumoniae DNA extracted from human respiratory specimens.
Technical Method A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens.
Target Area in vitro diagnostic assay
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOZX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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