GQW
10 FDA 510(k) clearances · Product code
188 daysmedian time to decision
378 days90th percentile
10clearances measured
FDA profile
- Official device name
- Antigen, Cf, (Including Cf Control), Varicella-Zoster
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3900
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 (K070206) | Diagnostic Hybrids, Inc. | 2007-08-30 |
| LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (K990141) | Light Diagnostics | 1999-10-19 |
| VZV ANTIGEN CONTROL SLIDES (K964872) | Viral Antigens, Inc. | 1997-03-18 |
| VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT (K942743) | Viro Research, Inc. | 1994-12-15 |
| VZVSCAN(TM) LATEX AGGUTINATION TEST (K912239) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-11 |
| VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (K903882) | Viral Antigens, Inc. | 1990-12-04 |
| VARICELLA ZOSTER VIRUS (K894622) | Bion Ent., Ltd. | 1989-10-24 |
| VARICELLA/ZOSTER VIRUS (K843676) | Institute Virion , Ltd. | 1985-09-26 |
| VARICELLA-ZOSTER(IGG) IFA TEST (K841434) | Zeus Scientific, Inc. | 1985-04-19 |
| VARICELLA-ZOSTER ANTIGENS & CONTROLS (K802938) | Orion Diagnostica, Inc. | 1980-12-31 |
Track GQW automatically
Every clearance here is in the API, with alerts when new ones post.