Product code NHY
- Device name
- Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3480
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.
- Source
- FDA openFDA device classification dataset