Panels › Microbiology › Product code GQX · Class 2
Antiserum, Cf, Varicella-Zoster
Regulation 866.3900
0510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in GQX
| Company | 510(k)s | Recalls |
|---|---|---|
| Flow Laboratories, Inc. | 2 | 0 |
| Gull Laboratories, Inc. | 2 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Calbiotech Inc | 0 | 1 |
| Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 0 | 1 |
| Electro-Nucleonics, Inc. | 1 | 0 |
| Great Lakes Bioscience | 1 | 0 |
| Idt, A Division of Whittaker M.A. Bioproducts | 1 | 0 |
| Light Diagnostics | 1 | 0 |
| Microbix Biosystems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 1996 | K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY Light Diagnostics | GQX |
| Jul 17, 1991 | K911301 | VZV IGM TEST Gull Laboratories, Inc. | GQX |
| Mar 10, 1989 | K883427 | VIRGO(R) VZV-IGG ELISA Electro-Nucleonics, Inc. | GQX |
| Mar 31, 1988 | K875358 | VZV TEST Gull Laboratories, Inc. | GQX |
| Apr 22, 1987 | K863317 | ENZYGNOST ANTI-VZV IGG TEST Behring Diagnostics, Inc. | GQX |
| Feb 4, 1986 | K853540 | FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY Idt, A Division of Whittaker M.A. Bioproducts | GQX |
| Nov 12, 1985 | K852930 | VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO Microbix Biosystems, Inc., CA | GQX |
| Jan 7, 1985 | K842096 | GLB VARICELLA-ZOSTER VIRUS FLUORESCENT Great Lakes Bioscience | GQX |
| Jun 25, 1984 | K841526 | ORTHO VARICELLA-ZOSTER VIRUS IDENT. Ortho Diagnostic Systems, Inc. | GQX |
| May 20, 1977 | K770810 | VARICELLA-ZOSTER FA LABELED PRESERUM Flow Laboratories, Inc. | GQX |
| May 20, 1977 | K770806 | VARICELLA-ZOSTER FA LABELLED (8-321 RF) Flow Laboratories, Inc. | GQX |
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