OMS — Novel Influenza A Virus, A/H5 Ns1 Protein Class II
FDA product code OMS covers "Novel Influenza A Virus, A/H5 Ns1 Protein", a Class II medical device regulated under 21 CFR 866.3332. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OMS
- Device Class
- Class II
- Regulation Number
- 866.3332
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein 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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K083278 | arbor vita corportation | AVC A/H5N1 FLU TEST | April 8, 2009 |