GQW · Antigen, Cf, (Including Cf Control), Varicella-Zoster
Microbiology · 21 CFR 866.3900 · Class 2
Overview
| Product Code | GQW |
|---|---|
| Device Name | Antigen, Cf, (Including Cf Control), Varicella-Zoster |
| Regulation | 21 CFR 866.3900 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 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 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | Diagnostic Hybrids, Inc. | Aug 30, 2007 | SESE |
| K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | Light Diagnostics | Oct 19, 1999 | SESE |
| K964872 | VZV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | Mar 18, 1997 | SESE |
| K942743 | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | Viro Research, Inc. | Dec 15, 1994 | SESE |
| K912239 | VZVSCAN(TM) LATEX AGGUTINATION TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 11, 1991 | SESE |
| K903882 | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | Viral Antigens, Inc. | Dec 4, 1990 | SESE |
| K894622 | VARICELLA ZOSTER VIRUS | Bion Ent., Ltd. | Oct 24, 1989 | SESE |
| K843676 | VARICELLA/ZOSTER VIRUS | Institute Virion , Ltd. | Sep 26, 1985 | SESE |
| K841434 | VARICELLA-ZOSTER(IGG) IFA TEST | Zeus Scientific, Inc. | Apr 19, 1985 | SESE |
| K802938 | 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
