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.

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
No devices found for this product code.

About Product Code OZX - Regulatory Context