Product code GQW
- Device name
- Antigen, Cf, (Including Cf Control), Varicella-Zoster
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3900
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070206 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | Diagnostic Hybrids, Inc. | 2007-08-30 |
| K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | Light Diagnostics | 1999-10-19 |
| K964872 | VZV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 |
| K942743 | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | Viro Research, Inc. | 1994-12-15 |
| K912239 | VZVSCAN(TM) LATEX AGGUTINATION TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-11 |
| K903882 | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | Viral Antigens, Inc. | 1990-12-04 |
| K894622 | VARICELLA ZOSTER VIRUS | Bion Ent., Ltd. | 1989-10-24 |
| K843676 | VARICELLA/ZOSTER VIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K841434 | VARICELLA-ZOSTER(IGG) IFA TEST | Zeus Scientific, Inc. | 1985-04-19 |
| K802938 | VARICELLA-ZOSTER ANTIGENS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G5229028011 | Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G5229028001 | Varicella-Zoster Virus / VZV IgG IFA 96 Test | Hemagen Diagnostics, Inc. | 2023-10-05 |
| 00860002913537 | ZosterGent VZV Identification Reagent | VIRO RESEARCH, LLC | 2020-10-30 |
| 00860002913506 | ZosterGent VZV Identification Reagent | VIRO RESEARCH, LLC | 2020-10-30 |
| 00860002913513 | ZosterGent VZV Identification Reagent | VIRO RESEARCH, LLC | 2020-10-30 |
| 00860002913568 | ZosterGent VZV Identification Reagent | VIRO RESEARCH, LLC | 2020-10-30 |
| 00860002913551 | ZosterGent VZV Identification Reagent | VIRO RESEARCH, LLC | 2020-10-30 |
| 00860002913544 | ZosterGent VZV Identification Reagent | VIRO RESEARCH, LLC | 2020-10-30 |
| 00860002913520 | ZosterGent VZV Identification Reagent | VIRO RESEARCH, LLC | 2020-10-30 |
| 04053252370960 | Light Diagnostics SimulFluor HSV/VZV Reagent | EMD Millipore Corporation | 2020-04-16 |
| 30014613330509 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-07-21 |
| 30014613330493 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2016-09-15 |
| B110VZ70120 | Varicella Zoster Virus Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110VZG70200 | Varicella Zoster IgG Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110VZM70300 | Varicella Zoster IgM Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110VZN70100 | Varicella Zoster Negative Control | Bion Enterprises, Ltd. | 2016-09-12 |
| 04053252371745 | Light Diagnostics™ Simulfluor® HSV / VZV DFA | EMD Millipore Corporation | 2016-09-09 |