Definition: A Qualitative In Vitro Diagnostic Assay For The Detection Of Dengue Virus Serotypes 1, 2, 3 Or 4 In Serum Or Plasma Specimens Collected From Human Patients With Signs And Symptoms Consistent With Dengue (mild Or Severe).
| Device Type ID | 3547 |
| Device Name | Dengue Nucleic Acid Amplification Assay (naat) |
| Physical State | Dengue Nucleic Acid Amplification And Detection Reagents Including Primers And Probes, Positive Controls, And Human Specimen Extraction Control |
| Technical Method | Uses Nucleic Acid Amplification Technology For Detection Of Dengue Virus Target Sequences |
| Target Area | Human Clinical Samples E.g., Blood Serum, Plasma |
| Regulation Description | Dengue Virus Nucleic Acid Amplification Test Reagents. |
| 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 | 866.3946 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |