Non-sars Coronavirus Multiplex Nucleic Acid Assay
Device Code: 3538
Product Code(s):
OTG Definition: A Non-SARS Coronavirus Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Coronavirus 229E, Coronavirus NL63, Coronavirus HKU1 And Coronavirus OC43 Nucleic Acids Isola
Device Classification Information
| Device Type ID | 3538 |
| Device Name | Non-sars Coronavirus Multiplex Nucleic Acid Assay |
| Physical State | Nucleic Acid Based Assay |
| Technical Method | Multiplex Nucleic Acid Assay |
| Target Area | IVD |
| Regulation Description | Respiratory Viral Panel Multiplex Nucleic Acid Assay. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OTG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3538 |
| Device | Non-sars Coronavirus Multiplex Nucleic Acid Assay |
| Product Code | OTG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Respiratory Viral Panel Multiplex Nucleic Acid Assay. |
| CFR Regulation Number | 866.3980 [🔎] |
TPLC Last Update: 2019-04-02 20:31:58