QDS — Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System Class II
Classification Details
- Product Code
- QDS
- Device Class
- Class II
- Regulation Number
- 866.4001
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Pathology
- Implant
- No
Definition
A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243222 | biofire diagnostics, llc (biomerieux) | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRA | November 6, 2024 |
| K222601 | biofire diagnostics | FilmArray Pneumonia Panel plus | October 27, 2022 |
| K181324 | biofire diagnostics | FilmArray Pneumonia Panel plus | November 15, 2018 |