Definition: An Influenza A And Influenza B Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Influenza A And Influenza B Nucleic Acids Isolated And Purified From Human Respirator
| Device Type ID | 3548 |
| Device Name | Influenza A And Influenza B 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 | OZE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3548 |
| Device | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Product Code | OZE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Respiratory Viral Panel Multiplex Nucleic Acid Assay. |
| CFR Regulation Number | 866.3980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALERE SCARBOROUGH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CENTERS FOR DISEASE CONTROL AND PREVENTION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
U.S. GOVERNMENT DEPARTMENT HHS | ||
SUBSTANTIALLY EQUIVALENT | 4 | |