Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
The MERS-CoV And Common Respiratory Pathogens Semi-Quantitative And 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 in human clinical specimens, intended for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria to aid in differential diagnosis in conjunction with other clinical and laboratory data. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.4001 in the Pathology specialty. The product code is QDS. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDS
- Device Class
- FDA class 2
- Regulation Number
- 866.4001
- Medical Specialty
- Pathology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
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 |
|---|---|---|---|---|
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Nov 06, 2024 | Substantially Equivalent | Biofire Diagnostics, LLC (Biomerieux) |
| K222601 | FilmArray Pneumonia Panel plus | Oct 27, 2022 | Substantially Equivalent | Biofire Diagnostics, LLC |
| K181324 | FilmArray Pneumonia Panel plus | Nov 15, 2018 | Substantially Equivalent | Biofire Diagnostics, LLC |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.