Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
The Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) RNA device (product code NXD) consists of primers, probes, and controls used in nucleic acid amplification tests to detect and differentiate novel influenza A virus-specific RNA gene segments, including the A/H5 Asian lineage subtype, in human respiratory specimens or viral cultures to aid in diagnosing and characterizing novel influenza A infections. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.3332 within the Microbiology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NXD
- Device Class
- FDA class 2
- Regulation Number
- 866.3332
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100287 | JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 | Jul 06, 2010 | Substantially Equivalent | U.S. Army Medical Material Development Command |
| K080570 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL | Sep 30, 2008 | Substantially Equivalent | Centers for Disease Control and Prevention |
| DEN060008 | INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET | Feb 03, 2006 | Unknown | Centers for Disease Control and Prevention |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.