Product code LGC
- Device name
- Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3305
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033059 | HERPES GROUP IGG | Trinity Biotech, Inc. | 2003-11-26 |
| K010878 | MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 | Diagnostic Products Corp. | 2001-04-18 |
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | Diamedix Corp. | 2000-11-28 |
| K000238 | HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G | Mrl Diagnostics | 2000-04-14 |
| K992166 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | 1999-09-03 |
| K983886 | POCKIT HSV 2 RAPID TEST | Diagnology , Ltd. | 1999-08-19 |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Meridian Diagnostics, Inc. | 1999-06-25 |
| K983656 | HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-03-18 |
| K983541 | HSV 1+2 IGG ELISA TEST | Gull Laboratories, Inc. | 1999-02-26 |
| K981306 | DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM | Diamedix Corp. | 1998-09-29 |
| K963645 | HERPES GROUP IGG ELISA TEST SYSTEM | Armkel, LLC | 1997-02-04 |
| K963282 | SERAQUEST HSV IGG | Quest Intl., Inc. | 1997-01-22 |
| K950670 | IMMULITE HERPES I AND II IGG | Diagnostic Products Corp. | 1996-06-21 |
| K953839 | PREMIER HSV PLUS | Meridian Diagnostics, Inc. | 1996-05-23 |
| K925208 | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | Ortho Diagnostic Systems, Inc. | 1992-12-28 |
| K922333 | BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA | Baxter Diagnostics, Inc. | 1992-12-15 |
| K922334 | BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA | Baxter Diagnostics, Inc. | 1992-12-15 |
| K922759 | HSV-2 IGM ELISA TEST--MODIFICATION | Gull Laboratories, Inc. | 1992-10-05 |
| K922758 | HSV-1 IGM ELISA TEST -- MODIFICATION | Gull Laboratories, Inc. | 1992-10-05 |
| K922583 | BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA | Baxter Diagnostics, Inc. | 1992-09-28 |
| K922584 | BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA | Baxter Diagnostics, Inc. | 1992-09-18 |
| K915551 | ORTHO HSV ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | 1992-04-22 |
| K910954 | HSV-1 IGG ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 |
| K910952 | HSV-2 IGG ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 |
| K910955 | HSV-1 IGM ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 |
| K910953 | HSV-2 IGM ELISA TEST | Gull Laboratories, Inc. | 1991-05-28 |
| K910499 | IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS | Vitek Systems, Inc. | 1991-05-01 |
| K903926 | KODAK SURECELL HERPES (HSV) CONTROL FLUID SET | Eastman Kodak Company | 1990-09-17 |
| K903070 | SEROCARD HSV IGG ANTIBODY TEST KIT | Disease Detection International, Inc. | 1990-08-09 |
| K900713 | HERPTRAN CONCENTRATE | E.I. Dupont DE Nemours & Co., Inc. | 1990-05-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850054026644 | QMedix™ | Diagnostic Automation, Inc. | 2024-06-25 |
| 08426951056439 | biokitHSV-2 | BIOKIT, S.A. | 2022-10-10 |
| 00894175000046 | AccuDiag ™ | Diagnostic Automation, Inc. | 2021-08-10 |
| B3507203400 | Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-08-28 |
| B3507203500 | Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-06-03 |
| 00630414016726 | ADVIA Centaur Herpes-2 IgG | Siemens Healthcare Diagnostics Inc. | 2019-04-09 |
| 00630414999784 | IMMULITE® 2000 Systems Herpes I and II IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414964171 | IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 05391516743709 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05391516746489 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 10816101021014 | HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 20816101021004 | HerpeSelect® 1 and 2 Immunoblot IgG | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101021038 | HSV-1 and HSV-2 Immunoblot IgG Negative Control | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101021021 | HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 00817273020174 | Diamedix | DIAMEDIX CORPORATION | 2016-09-20 |
| 05391516746496 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-19 |
| 00847865010740 | Bio-Rad Laboratories, Inc. | Bio-RAD Laboratories, Inc. | 2016-09-12 |
| 00850487007142 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00850487007333 | SeraQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00811727015211 | Pointe Scientific, Inc. HSV-1 & 2 IgG | HORIBA INSTRUMENTS INCORPORATED | 2016-08-31 |
| 00816057020577 | ASI HSV IgG EIA Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |