GQX
11 FDA 510(k) clearances · Product code
126 daysmedian time to decision
239 days90th percentile
11clearances measured
FDA profile
- Official device name
- Antiserum, Cf, 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 |
|---|---|---|
| VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951799) | Light Diagnostics | 1996-03-20 |
| VZV IGM TEST (K911301) | Gull Laboratories, Inc. | 1991-07-17 |
| VIRGO(R) VZV-IGG ELISA (K883427) | Electro-Nucleonics, Inc. | 1989-03-10 |
| VZV TEST (K875358) | Gull Laboratories, Inc. | 1988-03-31 |
| ENZYGNOST ANTI-VZV IGG TEST (K863317) | Behring Diagnostics, Inc. | 1987-04-22 |
| FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (K853540) | Idt, A Division of Whittaker M.A. Bioproducts | 1986-02-04 |
| VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (K852930) | Microbix Biosystems, Inc. | 1985-11-12 |
| GLB VARICELLA-ZOSTER VIRUS FLUORESCENT (K842096) | Great Lakes Bioscience | 1985-01-07 |
| ORTHO VARICELLA-ZOSTER VIRUS IDENT. (K841526) | Ortho Diagnostic Systems, Inc. | 1984-06-25 |
| VARICELLA-ZOSTER FA LABELLED (8-321 RF) (K770806) | Flow Laboratories, Inc. | 1977-05-20 |
| VARICELLA-ZOSTER FA LABELED PRESERUM (K770810) | Flow Laboratories, Inc. | 1977-05-20 |
Track GQX automatically
Every clearance here is in the API, with alerts when new ones post.