Panels › Microbiology › Product code GQW · Class 2
Antigen, Cf, (Including Cf Control), Varicella-Zoster
Regulation 866.3900
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GQW
| Company | 510(k)s | Recalls |
|---|---|---|
| Viral Antigens, Inc. | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Bion Ent., Ltd. | 1 | 0 |
| Diagnostic Hybrids, Inc. | 1 | 0 |
| Institute Virion , Ltd. | 1 | 0 |
| Light Diagnostics | 1 | 0 |
| Orion Diagnostica, Inc. | 1 | 0 |
| Viro Research, Inc. | 1 | 0 |
| Zeus Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 30, 2007 | K070206 | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 Diagnostic Hybrids, Inc. | GQW |
| Oct 19, 1999 | K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 Light Diagnostics | GQW |
| Mar 18, 1997 | K964872 | VZV ANTIGEN CONTROL SLIDES Viral Antigens, Inc. | GQW |
| Dec 15, 1994 | K942743 | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT Viro Research, Inc. | GQW |
| Jun 11, 1991 | K912239 | VZVSCAN(TM) LATEX AGGUTINATION TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | GQW |
| Dec 4, 1990 | K903882 | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG Viral Antigens, Inc. | GQW |
| Oct 24, 1989 | K894622 | VARICELLA ZOSTER VIRUS Bion Ent., Ltd. | GQW |
| Sep 26, 1985 | K843676 | VARICELLA/ZOSTER VIRUS Institute Virion , Ltd. | GQW |
| Apr 19, 1985 | K841434 | VARICELLA-ZOSTER(IGG) IFA TEST Zeus Scientific, Inc. | GQW |
| Dec 31, 1980 | K802938 | VARICELLA-ZOSTER ANTIGENS & CONTROLS Orion Diagnostica, Inc. | GQW |
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