Product code QDS— Pathology
FilmArray Pneumonia Panel plus
- Classification name
- Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
- Device class
- Class 2
- Regulation
- 21 CFR 866.4001
- Advisory panel
- Pathology
- Total cleared
- 3
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QDS
FDA has cleared devices under product code QDS between 2018 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2022
- 2018
Top applicants under product code QDS
Adverse events under product code QDS
product code QDS- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code QDS
Data sourced from openFDA. This site is unofficial and independent of the FDA.