MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
Device Facts
| Record ID | K861379 |
|---|---|
| Device Name | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT |
| Applicant | Serono Diagnostics, Inc. |
| Product Code | LKT · Microbiology |
| Decision Date | Jul 16, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3480 |
| Device Class | Class 1 |
Regulatory Classification
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.
