GQX · Antiserum, Cf, Varicella-Zoster
Microbiology · 21 CFR 866.3900 · Class 2
Overview
| Product Code | GQX |
|---|---|
| Device Name | Antiserum, Cf, 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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | Mar 20, 1996 | SESE |
| K911301 | VZV IGM TEST | Gull Laboratories, Inc. | Jul 17, 1991 | SESE |
| K883427 | VIRGO(R) VZV-IGG ELISA | Electro-Nucleonics, Inc. | Mar 10, 1989 | SESE |
| K875358 | VZV TEST | Gull Laboratories, Inc. | Mar 31, 1988 | SESE |
| K863317 | ENZYGNOST ANTI-VZV IGG TEST | Behring Diagnostics, Inc. | Apr 22, 1987 | SESE |
| K853540 | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY | Idt, A Division of Whittaker M.A. Bioproducts | Feb 4, 1986 | SESE |
| K852930 | VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO | Microbix Biosystems, Inc. | Nov 12, 1985 | SESE |
| K842096 | GLB VARICELLA-ZOSTER VIRUS FLUORESCENT | Great Lakes Bioscience | Jan 7, 1985 | SESE |
| K841526 | ORTHO VARICELLA-ZOSTER VIRUS IDENT. | Ortho Diagnostic Systems, Inc. | Jun 25, 1984 | SESE |
| K770810 | VARICELLA-ZOSTER FA LABELED PRESERUM | Flow Laboratories, Inc. | May 20, 1977 | SESE |
| K770806 | 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
