NHY — Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus Class I
FDA product code NHY covers "Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus", a Class I medical device regulated under 21 CFR 866.3480. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- NHY
- Device Class
- Class I
- Regulation Number
- 866.3480
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.