Panels › Microbiology › Product code LGC · Class 2
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Regulation 866.3305
0510(k)s in 12 months (38 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LGC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2023 | Biokit, S.A. biokitHSV-2 Rapid Test, REF: 300028001 Open, Classified |
LGC | K983886 |
| May 10, 2012 | Diamedix Corporation Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient Terminated |
LGC | K002262 |
| Mar 11, 2011 | BioCheck Inc HSV-2 IgG ELISA kit ;
HSV-2 IgM ELISA kit;
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LGC | None listed |
| Mar 11, 2011 | BioCheck Inc HSV-1 IgG ELISA kit ;
HSV-1 IgM ELISA kit;
BioCheck, Foster City, CA 9440.
Quantitative determination of AFP concentration in human serum. Terminated |
LGC | None listed |
| Jul 8, 2010 | Biokit U.S.A. Inc. Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395.
20 test Kit
In Vitro Diagnostic test for Herpes Simplex Virus 2 Terminated |
LGC | K983886 |
| Jul 8, 2010 | Biokit U.S.A. Inc. Biokit HSV-2 Rapid test Catalogue Number: 3000-28001.
20 test Kit.
In Vitro Diagnostic test for Herpes Simplex Virus 2. Terminated |
LGC | K983886 |
| Aug 17, 2008 | Focus Diagnostics Inc HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G
Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. Terminated |
LGC | K000238 |
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