Product code
NXD: Nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
FDA product code · Class II · Microbiology
Key facts
| Product code | NXD |
|---|---|
| Device | Nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna |
| Device class | Class II |
| Regulation number | 866.3332 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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… |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database