Home › Device types › LGC
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
FDA product code LGC · Class 2 · Microbiology
21
Registered devices
13
Adverse events
7
Recalls
38
510(k) clearances
Devices with this code
biokitHSV-2 — BIOKIT, S.A.HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control — DIASORIN MOLECULAR LLCSeraQuest — QUEST INTERNATIONAL, INC.HSV-1 and HSV-2 Immunoblot IgG Negative Control — DIASORIN MOLECULAR LLCGold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit — Gold Standard Diagnostics CorporationASI HSV IgG EIA Test — ARLINGTON SCIENTIFIC, INC.Trinity Biotech — CLARK LABORATORIES, INC.AccuDiag ™ — Diagnostic Automation, Inc.Diamedix — DIAMEDIX CORPORATIONQMedix™ — Diagnostic Automation, Inc.Trinity Biotech — CLARK LABORATORIES, INC.Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit — Gold Standard Diagnostics CorporationHSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips — DIASORIN MOLECULAR LLCTrinity Biotech — CLARK LABORATORIES, INC.Bio-Rad Laboratories, Inc. — Bio-RAD Laboratories, Inc.HerpeSelect® 1 and 2 Immunoblot IgG — DIASORIN MOLECULAR LLCADVIA Centaur Herpes-2 IgG — Siemens Healthcare Diagnostics Inc.ReQuest — QUEST INTERNATIONAL, INC.IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDPointe Scientific, Inc. HSV-1 & 2 IgG — HORIBA INSTRUMENTS INCORPORATEDIMMULITE® 2000 Systems Herpes I and II IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-28 | Biokit, S.A. | HSV-2 rapid test may report false positive results. |
| 2012-01-16 | Diamedix Corporation | On 01/16/20112 Diamedix initiated a recall of IS-HSV 1&2 IgM Test Kit, Catalog # 720-350, Lot 60701, Exp. June 30, 2012. The Positive Control for this lot is O |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-04-14 | Biokit U.S.A. Inc. | Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. |
| 2010-04-14 | Biokit U.S.A. Inc. | Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. |
| 2007-07-06 | Focus Diagnostics Inc | A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced react |
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