| Device |
nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna |
| Regulation Description |
Reagents for detection of specific novel influenza A viruses. |
| Definition |
Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures.Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses.They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza.These reagents are primers and probes, along with a specific novel influenza virus control. |
| Physical State |
OIVD |
| Technical Method |
Direct nucleic acid amplification |
| Target Area |
specific RNA segment |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | NXD |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3332
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Documents
- Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
- Reagents for Detection of Specific Novel Influenza A Viruses : Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document
|
|
| Third Party Review |
Not Third Party Eligible |
