OZX
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mycoplasma Pneumoniae Dna Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Medical specialty
- Microbiology
- 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.
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| Record | Firm | Date |
|---|---|---|
| illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 (K160829) | Meridian Bioscience, Inc. | 2016-06-13 |
| illumigene Mycoplasma DNA Amplification Assay (K152800) | Meridian Bioscience, Inc. | 2015-10-23 |
| ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT (K123423) | Meridian Bioscience, Inc. | 2013-06-05 |
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