Mycoplasma Pneumoniae Dna Assay System
The Mycoplasma Pneumoniae DNA Assay System is a qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens, aiding in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients with signs and symptoms of upper respiratory tract infection. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZX, with regulation number 866.3980 under the Microbiology medical specialty.
Research product code OZX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OZX
- Device Class
- FDA class 2
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | Jun 13, 2016 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K152800 | illumigene Mycoplasma DNA Amplification Assay | Oct 23, 2015 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT | Jun 05, 2013 | Substantially Equivalent | Meridian Bioscience, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.