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OZX — Mycoplasma Pneumoniae Dna Assay System Class II

FDA Device Classification

Classification Details

Product Code
OZX
Device Class
Class II
Regulation Number
866.3980
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160829meridian bioscienceillumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma DireJune 13, 2016
K152800meridian bioscienceillumigene Mycoplasma DNA Amplification AssayOctober 23, 2015
K123423meridian bioscienceILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNJune 5, 2013