21 CFR 866.3480 — Antiserum, Neutralization, Respiratory Syncytial Virus
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3480
Identification
Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GQF | Antiserum, Neutralization, Respiratory Syncytial Virus | 1 | 0 | |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 32 | |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 | 23 | |
| MCE | Respiratory Syncytial Virus - Elisa | 1 | 2 | |
| NHY | Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus | 1 | 0 | 3rd Party |
