NXD — Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna Class II
FDA product code NXD covers "Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna", a Class II medical device regulated under 21 CFR 866.3332. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NXD
- 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 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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K100287 | u.s. army medical material development command | JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 | July 6, 2010 |
| K080570 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL | September 30, 2008 |
| DEN060008 | centers for disease control and prevention | INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET | February 3, 2006 |