Antigen, Cf, (Including Cf Control), Varicella-Zoster
The Antigen, CF (Including CF Control), Varicella-Zoster is a complement fixation antigen with controls used in clinical laboratories to detect antibodies to the varicella-zoster virus (VZV), the causative agent of chickenpox and shingles. It is an FDA Class 2 device, carrying moderate risk and requiring 510(k) premarket clearance prior to marketing. The product code is GQW, regulated under 21 CFR 866.3900 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GQW
- Device Class
- FDA class 2
- Regulation Number
- 866.3900
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070206 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | Aug 30, 2007 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | Oct 19, 1999 | Substantially Equivalent | Light Diagnostics |
| K964872 | VZV ANTIGEN CONTROL SLIDES | Mar 18, 1997 | Substantially Equivalent | Viral Antigens, Inc. |
| K942743 | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | Dec 15, 1994 | Substantially Equivalent | Viro Research, Inc. |
| K912239 | VZVSCAN(TM) LATEX AGGUTINATION TEST | Jun 11, 1991 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K903882 | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | Dec 04, 1990 | Substantially Equivalent | Viral Antigens, Inc. |
| K894622 | VARICELLA ZOSTER VIRUS | Oct 24, 1989 | Substantially Equivalent | Bion Ent., Ltd. |
| K843676 | VARICELLA/ZOSTER VIRUS | Sep 26, 1985 | Substantially Equivalent | Institute Virion , Ltd. |
| K841434 | VARICELLA-ZOSTER(IGG) IFA TEST | Apr 19, 1985 | Substantially Equivalent | Zeus Scientific, Inc. |
| K802938 | VARICELLA-ZOSTER ANTIGENS & CONTROLS | Dec 31, 1980 | Substantially Equivalent | Orion Diagnostica, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.