VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
Device Facts
| Record ID | K923122 |
|---|---|
| Device Name | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM |
| Applicant | Biomerieux Vitek, Inc. |
| Product Code | LFY · Microbiology |
| Decision Date | Oct 26, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.
