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) → GQW — Antigen, Cf, (Including Cf Control), Varicella-Zoster

# GQW · Antigen, Cf, (Including Cf Control), Varicella-Zoster

_Microbiology · 21 CFR 866.3900 · Class 2_

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

## Overview

- **Product Code:** GQW
- **Device Name:** Antigen, Cf, (Including Cf Control), 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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K070206](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K070206.md) | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | Diagnostic Hybrids, Inc. | Aug 30, 2007 | SESE |
| [K990141](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K990141.md) | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | Light Diagnostics | Oct 19, 1999 | SESE |
| [K964872](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K964872.md) | VZV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | Mar 18, 1997 | SESE |
| [K942743](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K942743.md) | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | Viro Research, Inc. | Dec 15, 1994 | SESE |
| [K912239](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K912239.md) | VZVSCAN(TM) LATEX AGGUTINATION TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 11, 1991 | SESE |
| [K903882](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K903882.md) | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | Viral Antigens, Inc. | Dec 4, 1990 | SESE |
| [K894622](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K894622.md) | VARICELLA ZOSTER VIRUS | Bion Ent., Ltd. | Oct 24, 1989 | SESE |
| [K843676](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K843676.md) | VARICELLA/ZOSTER VIRUS | Institute Virion , Ltd. | Sep 26, 1985 | SESE |
| [K841434](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K841434.md) | VARICELLA-ZOSTER(IGG) IFA TEST | Zeus Scientific, Inc. | Apr 19, 1985 | SESE |
| [K802938](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GQW/K802938.md) | VARICELLA-ZOSTER ANTIGENS & CONTROLS | Orion Diagnostica, Inc. | Dec 31, 1980 | SESE |

## Top Applicants

- Viral Antigens, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bion Ent., Ltd. — 1 clearance
- Diagnostic Hybrids, Inc. — 1 clearance
- Institute Virion , Ltd. — 1 clearance

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

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