Definition: The Variola Virus Nucleic Acid-based Detection Assay Is Intended For Individuals Presenting With Pustular Or Vesicular Rash Illness Or Other Signs And Symptoms Of Variola Virus Infection. The Test Results Must Be Used In Conjunction With Other Diagno
| Device Type ID | 3576 |
| Device Name | Variola Virus Nucleic Acid-based Detection Assay |
| Physical State | The Variola Virus Nucleic Acid-based Detection Assays Are In Vitro Diagnostic Devices That Consist Of Reagents And Associated Instrumentation For The Detection And Identification Of Variola Virus Nucleic Acids In Human Clinical Specimens. |
| Technical Method | Qualitative In Vitro Diagnostic Assay That Detects And Identifies Variola Virus Nucleic Acids In Human Clinical Specimens. |
| Target Area | In Vitro Diagnostic Device |
| 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 | 866.3316 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PRA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3576 |
| Device | Variola Virus Nucleic Acid-based Detection Assay |
| Product Code | PRA |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3316 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) | ||
GRANTED | 1 | |