# Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
> **Product code: QDS** · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 866.4001
## Classification
- **FDA Product Code:** QDS
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.4001
- **Review panel:** MI
- **Medical specialty:** Pathology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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 data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QDS)
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