Definition: Qualitative In Vitro Diagnostic Test For The Rapid Detection And Differentiation Of Norovirus Genogroup I And Genogroup II From Specimens E.g., Stool Collected From Individuals With Symptoms Of Acute Gastroenteritis.
| Device Type ID | 3566 |
| Device Name | Reagents For Detection Of Norovirus Nucleic Acid |
| Physical State | The Device/system Consists Of An Instrument, Personal Computer, And Preloaded Software For Running The Tests And Viewing The Results. |
| Technical Method | Instrument Systems Automate And Integrate Sample Preparation, Nucleic Acid Extraction And Amplification, And Detection Of The Target Sequences In Simple Or Complex Samples Using Reverse Transcriptase PCR (RT-PCR) And Real-time PCR Assays. |
| Target Area | Noninvasive |
| Regulation Description | Gastrointestinal Microorganism Multiplex Nucleic Acid-based 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 | 866.3990 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3566 |
| Device | Reagents For Detection Of Norovirus Nucleic Acid |
| Product Code | PIQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Microorganism Multiplex Nucleic Acid-based Assay. |
| CFR Regulation Number | 866.3990 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
R-BIOPHARM AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |