NXD
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3332
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 (K100287) | U.S. Army Medical Material Development Command | 2010-07-06 | + Add |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL (K080570) | Centers for Disease Control and Prevention | 2008-09-30 | + Add |
| INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET (DEN060008) | Centers for Disease Control and Prevention | 2006-02-03 |
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