OZX · Class II · 21 CFR 866.3980

FDA Product Code OZX: Mycoplasma Pneumoniae Dna Assay System

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.

Leading manufacturers include Meridian Bioscience, Inc..

3
Total
3
Cleared
105d
Avg days
2013
Since

FDA 510(k) Cleared Mycoplasma Pneumoniae Dna Assay System Devices (Product Code OZX)

3 devices
1–3 of 3
Cleared Jun 13, 2016
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
K160829
Meridian Bioscience, Inc.
Microbiology · 80d
Cleared Oct 23, 2015
illumigene Mycoplasma DNA Amplification Assay
K152800
Meridian Bioscience, Inc.
Microbiology · 25d
Cleared Jun 05, 2013
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
K123423
Meridian Bioscience, Inc.
Microbiology · 211d

About Product Code OZX - Regulatory Context