OZXClass II
Mycoplasma Pneumoniae Dna Assay System
21 CFR 866.3980 / Microbiology
OZX is the FDA product code for Mycoplasma Pneumoniae Dna Assay System, a class II device type, regulated under 21 CFR 866.3980. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OZX
- Device name
- Mycoplasma Pneumoniae Dna Assay System
- FDA 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.
- Regulation
- 21 CFR 866.3980
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code OZX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
Applicants with the most clearances
Product code OZX| Applicant | Clearances |
|---|---|
| Meridian Bioscience Inc | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.