BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
Device Facts
| Record ID | K924006 |
|---|---|
| Device Name | BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY |
| Applicant | Baxter Healthcare Corp |
| Product Code | GNX · Microbiology |
| Decision Date | Dec 29, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3330 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.
