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 Qu
| Device Type ID | 3597 |
| Device Name | Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System |
| Physical State | Middle East Respiratory Syndrome Coronavirus (MERS-CoV) And Common Respiratory Pathogens Semi-quantitative Or Quantitative Multiplex Nucleic Acid Detection Systems Are In Vitro Diagnostic Devices That Consist Of Reagents And Associated Instrumentatio |
| Technical Method | A Qualitative, Semi-quantitative Or Quantitative In Vitro Diagnostic Assay That Detects And Identifies MERS-CoV And Common Respiratory Pathogens – Associated Nucleic Acids In Human Clinical Specimens. |
| Target Area | Human Clinical Samples |
| Regulation Medical Specialty | Pathology |
| Review Panel | Microbiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.4001 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3597 |
| Device | Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System |
| Product Code | QDS |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.4001 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |