OZX — Mycoplasma Pneumoniae Dna Assay System Class II
FDA product code OZX covers "Mycoplasma Pneumoniae Dna Assay System", a Class II medical device regulated under 21 CFR 866.3980. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K160829 | meridian bioscience | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Dire | June 13, 2016 |
| K152800 | meridian bioscience | illumigene Mycoplasma DNA Amplification Assay | October 23, 2015 |
| K123423 | meridian bioscience | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERN | June 5, 2013 |