Definition: A Qualitative In Vitro Diagnostic Assay Intended To Detect Human Metapneumovirus (hmpv) Rna Extracted From Human Respiratory Specimens Or Viral Cultures. Detection Of Hmpv Rna Aids In The Diagnosis Of Respiratory Hmpv Infection In Conjunction With Ot
| Device Type ID | 3526 |
| Device Name | Human Metapneumovirus (hmpv) Rna Assay System |
| Physical State | Human Metapneumovirus (hMPV) RNA Detection Assay Systems Are Devices That Consist Of Reagents And Instruments For The Detection Of HMPV RNA Extracted From Human Respiratory Specimens Or Viral Cultures. |
| Technical Method | A Qualitative In Vitro Diagnostic Assay Intended To Detect Human Metapneumovirus (hMPV) RNA Extracted From Human Respiratory Specimens Or Viral Cultures. |
| Target Area | In Vitro Diagnostic Assay |
| 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)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.3980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |