Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
FDA product code LGC · Class II (moderate risk) · 21 CFR 866.3305 · Microbiology
38510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Gull Laboratories, Inc. 7
- Baxter Diagnostics, Inc. 4
- Ortho Diagnostic Systems, Inc. 3
- Eastman Kodak Company 2
- Disease Detection International, Inc. 2
- Zeus Scientific, Inc. 2
- Diamedix Corp. 2
- Meridian Diagnostics, Inc. 2
- Diagnostic Products Corp. 2
- Trinity Biotech, Plc 1
- Bartels & Stout, Inc. 1
- Mrl Diagnostics 1
- Diagnology , Ltd. 1
- Armkel, LLC 1
- Quest Intl., Inc. 1
- Vitek Systems, Inc. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- Boots-Celltech Diagnostics, Inc. 1
- Scientific Research 1
- Abbott Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033059 | Herpes Group IggLGC · Traditional | Trinity Biotech, Inc. | 11/26/2003SE |
| K010878 | Modification to Immulite Herpes I & II Igg, Model L2KHS2 & L2KHS6LGC · Special | Diagnostic Products Corp. | 04/18/2001SE |
| K002262 | Diamedix Is-Hsv 1&2 Igm Test SystemLGC · Traditional | Diamedix Corp. | 11/28/2000SE |
| K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GLGC · Traditional | Mrl Diagnostics | 04/14/2000SE |
| K992166 | The Aptus (Automated) Application of the HSV 1/2 Igm Elisa Test System. an Enzyme Linked…LGC · Traditional | Zeus Scientific, Inc. | 09/03/1999SE |
| K983886 | Pockit HSV 2 Rapid TestLGC · Traditional | Diagnology , Ltd. | 08/19/1999SE |
| K984346 | Premier Type Specific HSV-2 Igg Elisa TestLGC · Traditional | Meridian Diagnostics, Inc. | 06/25/1999SE |
| K983656 | HSV-1 And/Or -2 Igm Elisa Test SystemLGC · Traditional | Zeus Scientific, Inc. | 03/18/1999SE |
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | Gull Laboratories, Inc. | 02/26/1999SE |
| K981306 | Diamedix Is-Hsv 1 & 2 Igg Test SystemLGC · Traditional | Diamedix Corp. | 09/29/1998SE |
| K963645 | Herpes Group Igg Elisa Test SystemLGC · Traditional | Armkel, LLC | 02/04/1997SE |
| K963282 | Seraquest HSV IggLGC · Traditional | Quest Intl., Inc. | 01/22/1997SE |
| K950670 | Immulite Herpes I and II IggLGC · Traditional | Diagnostic Products Corp. | 06/21/1996SE |
| K953839 | Premier HSV PlusLGC · Traditional | Meridian Diagnostics, Inc. | 05/23/1996SE |
| K925208 | Ortho HSV Antigen Elisa Test, ModificationLGC · Traditional | Ortho Diagnostic Systems, Inc. | 12/28/1992SE |
| K922334 | Bartels Herpes Simplex Virus 1 Igm EiaLGC · Traditional | Baxter Diagnostics, Inc. | 12/15/1992SE |
| K922333 | Bartels Herpes Simplex Virus 2 Igm EiaLGC · Traditional | Baxter Diagnostics, Inc. | 12/15/1992SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | Gull Laboratories, Inc. | 10/05/1992SE |
| K922758 | HSV-1 Igm Elisa Test -- ModificationLGC · Traditional | Gull Laboratories, Inc. | 10/05/1992SE |
| K922583 | Bartels Herpes Simplex Virus 2 Igg EiaLGC · Traditional | Baxter Diagnostics, Inc. | 09/28/1992SE |
| K922584 | Bartels Herpes Simplex Virus 1 Igg EiaLGC · Traditional | Baxter Diagnostics, Inc. | 09/18/1992SE |
| K915551 | Ortho HSV Antigen Elisa TestLGC · Traditional | Ortho Diagnostic Systems, Inc. | 04/22/1992SE |
| K910955 | HSV-1 Igm Elisa TestLGC · Traditional | Gull Laboratories, Inc. | 05/28/1991SE |
| K910954 | HSV-1 Igg Elisa TestLGC · Traditional | Gull Laboratories, Inc. | 05/28/1991SE |
| K910953 | HSV-2 Igm Elisa TestLGC · Traditional | Gull Laboratories, Inc. | 05/28/1991SE |
| K910952 | HSV-2 Igg Elisa TestLGC · Traditional | Gull Laboratories, Inc. | 05/28/1991SE |
| K910499 | Immunodiagnostic Assay System Herpes Simplex VirusLGC · Traditional | Vitek Systems, Inc. | 05/01/1991SE |
| K903926 | Kodak Surecell Herpes (HSV) Control Fluid SetLGC · Traditional | Eastman Kodak Company | 09/17/1990SE |
| K903070 | Serocard HSV Igg Antibody Test KitLGC · Traditional | Disease Detection International, Inc. | 08/09/1990SE |
| K900713 | Herptran ConcentrateLGC · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/11/1990SE |
| K871877 | Ideia Herpes Simplex Virus TestLGC · Traditional | Boots-Celltech Diagnostics, Inc. | 11/17/1989SE |
| K884246 | Modified Ddi Serocard Herpes Igg Test KitLGC · Traditional | Disease Detection International, Inc. | 04/10/1989SE |
| K884680 | Kodak Surecell Herpes (HSV) Test KitLGC · Traditional | Eastman Kodak Company | 02/16/1989SE |
| K843077 | Elisa for Herpes Simplex VirusLGC · Traditional | Scientific Research | 06/21/1985SE |
| K843622 | Abbott HSV EiaLGC · Traditional | Abbott Laboratories | 05/20/1985SE |
| K834449 | HSV Antigen Elisa KitLGC · Traditional | Ortho Diagnostic Systems, Inc. | 05/02/1984SE |
| K822883 | Herpelisa KitLGC · Traditional | M.A. Bioproducts | 07/26/1983SE |
| K802526 | Test Kit for Detection of Herpes SimplexLGC · Traditional | Bartels & Stout, Inc. | 02/09/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1021-2023 Class II | biokitHSV-2 Rapid Test, REF: 300028001HSV-2 rapid test may report false positive results. | Biokit, S.A. | 09/28/2022Open, Classified |
| Z-1520-2012 | Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay…On 01/16/20112 Diamedix initiated a recall of IS-HSV 1&2 IgM Test Kit, Catalog # 720-350, Lot 60701, Exp.… | Diamedix Corporation | 01/16/2012Terminated |
| Z-1640-2011 | HSV-2 IgG ELISA kit ; HSV-2 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |
| Z-1639-2011 | HSV-1 IgG ELISA kit ; HSV-1 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |
| Z-1971-2010 | Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test…Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis… | Biokit U.S.A. Inc. | 04/14/2010Terminated |
| Z-1970-2010 | Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic…Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis… | Biokit U.S.A. Inc. | 04/14/2010Terminated |
| Z-1764-2008 | HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the…A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less… | Focus Diagnostics Inc | 07/06/2007Terminated |