Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3900](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3900) → GQX — Antiserum, Cf, Varicella-Zoster

# GQX · Antiserum, Cf, Varicella-Zoster

_Microbiology · 21 CFR 866.3900 · Class 2_

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

## Overview

- **Product Code:** GQX
- **Device Name:** Antiserum, Cf, Varicella-Zoster
- **Regulation:** [21 CFR 866.3900](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3900)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K951799](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K951799.md) | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | Mar 20, 1996 | SESE |
| [K911301](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K911301.md) | VZV IGM TEST | Gull Laboratories, Inc. | Jul 17, 1991 | SESE |
| [K883427](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K883427.md) | VIRGO(R) VZV-IGG ELISA | Electro-Nucleonics, Inc. | Mar 10, 1989 | SESE |
| [K875358](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K875358.md) | VZV TEST | Gull Laboratories, Inc. | Mar 31, 1988 | SESE |
| [K863317](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K863317.md) | ENZYGNOST ANTI-VZV IGG TEST | Behring Diagnostics, Inc. | Apr 22, 1987 | SESE |
| [K853540](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K853540.md) | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY | Idt, A Division of Whittaker M.A. Bioproducts | Feb 4, 1986 | SESE |
| [K852930](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K852930.md) | VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO | Microbix Biosystems, Inc. | Nov 12, 1985 | SESE |
| [K842096](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K842096.md) | GLB VARICELLA-ZOSTER VIRUS FLUORESCENT | Great Lakes Bioscience | Jan 7, 1985 | SESE |
| [K841526](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K841526.md) | ORTHO VARICELLA-ZOSTER VIRUS IDENT. | Ortho Diagnostic Systems, Inc. | Jun 25, 1984 | SESE |
| [K770810](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K770810.md) | VARICELLA-ZOSTER FA LABELED PRESERUM | Flow Laboratories, Inc. | May 20, 1977 | SESE |
| [K770806](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQX/K770806.md) | VARICELLA-ZOSTER FA LABELLED (8-321 RF) | Flow Laboratories, Inc. | May 20, 1977 | SESE |

## Top Applicants

- Flow Laboratories, Inc. — 2 clearances
- Gull Laboratories, Inc. — 2 clearances
- Behring Diagnostics, Inc. — 1 clearance
- Electro-Nucleonics, Inc. — 1 clearance
- Great Lakes Bioscience — 1 clearance

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

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