Definition: A Qualitative In Vitro Diagnostic Assay Intended To Detect And Differentiate Between Influenza A Virus Subtypes In Human Respiratory Specimens Or Viral Culture. Detection And Differentiation Of Specific Subtype Rna Aids In The Diagnosis Of Influenza
| Device Type ID | 3527 |
| Device Name | Influenza A Virus Subtype Differentiation Nucleic Acid Assay |
| Physical State | OIVD |
| Technical Method | Direct Nucleic Acid Detection |
| Target Area | Specific RNA Segments |
| 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 | OEP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3527 |
| Device | Influenza A Virus Subtype Differentiation Nucleic Acid Assay |
| Product Code | OEP |
| 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 | |
CENTERS FOR DISEASE CONTROL AND PREVENTION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U.S. GOVERNMENT DEPARTMENT HHS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |