← Product Code [GQX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX) · K853540

# FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (K853540)

_Idt, A Division of Whittaker M.A. Bioproducts · GQX · Feb 4, 1986 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K853540

## Device Facts

- **Applicant:** Idt, A Division of Whittaker M.A. Bioproducts
- **Product Code:** [GQX](/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX.md)
- **Decision Date:** Feb 4, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3900
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K853540](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K853540)

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