Definition: A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Detection And Identification Of MERS-CoV And Common Respiratory Patho
| Device Type ID | 3596 |
| Device Name | Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System |
| Physical State | Middle East Respiratory Syndrome Coronavirus (MERS-CoV) And Common Respiratory Pathogens Multiplex Nucleic Acid Detection Systems Are In Vitro Diagnostic Devices That Consist Of Reagents And Associated Instrumentation For Detection And Identification |
| Technical Method | A Qualitative In Vitro Diagnostic Assay That Detects And Identifies MERS-CoV And Common Respiratory Pathogens – Associated Nucleic Acids In Human Clinical Specimens. |
| Target Area | In Vitro Diagnostic Device |
| Regulation Medical Specialty | Pathology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.4001 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3596 |
| Device | Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System |
| Product Code | PZF |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.4001 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX SA | ||
GRANTED | 1 | |