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 |