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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2012 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests.
For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antib Terminated |
GQX | K883427 |
| Mar 5, 2010 | Calbiotech Inc VZV IgM ELISA 96 Well Kit, Catalog Number: VZ082M
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
GQX | None listed |
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