Antiserum, Cf, Varicella-Zoster
FDA product code GQX · Class II (moderate risk) · 21 CFR 866.3900 · Microbiology
11510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951799 | Varicella-Zoster Virus Direct Immunofluorescence AssayGQX · Traditional | Light Diagnostics | 03/20/1996SE |
| K911301 | VZV Igm TestGQX · Traditional | Gull Laboratories, Inc. | 07/17/1991SE |
| K883427 | Virgo(R) Vzv-Igg ElisaGQX · Traditional | Electro-Nucleonics, Inc. | 03/10/1989SE |
| K875358 | VZV TestGQX · Traditional | Gull Laboratories, Inc. | 03/31/1988SE |
| K863317 | Enzygnost Anti-Vzv Igg TestGQX · Traditional | Behring Diagnostics, Inc. | 04/22/1987SE |
| K853540 | Fiax Test Kit for Varicella Antibody SerologyGQX · Traditional | Idt, A Division of Whittaker M.A. Bioproducts | 02/04/1986SE |
| K852930 | Varicella-Zoster-Comple Fix Antigen and Neg ControGQX · Traditional | Microbix Biosystems, Inc. | 11/12/1985SE |
| K842096 | GLB Varicella-Zoster Virus FluorescentGQX · Traditional | Great Lakes Bioscience | 01/07/1985SE |
| K841526 | Ortho Varicella-Zoster Virus Ident.GQX · Traditional | Ortho Diagnostic Systems, Inc. | 06/25/1984SE |
| K770810 | Varicella-Zoster Fa Labeled PreserumGQX · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
| K770806 | Varicella-Zoster Fa Labelled (8-321 RF)GQX · Traditional | Flow Laboratories, Inc. | 05/20/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2445-2012 Class III | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601:…The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high… | Clark Laboratories, Inc. (dba,Trinity… | 05/29/2012Terminated |
| Z-1004-2010 | VZV IgM ELISA 96 Well Kit, Catalog Number: VZ082M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | Calbiotech Inc | 08/27/2008Terminated |