Product code MXJ
- Device name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- 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
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | Biokit, S.A. | 2023-09-20 |
| K220923 | Elecsys HSV-1 IgG (08948844160) | Roche Diagnostics | 2022-10-12 |
| K181333 | ADVIA Centaur Herpes-1 IgG | Biokit, S.A. | 2018-08-23 |
| K162276 | SeraQuest Herpes Type 1 Specific IgG | Quest International, Inc. | 2016-10-01 |
| K143236 | Theranos Herpes Simplex Virus-1 IgG Assay | Theranos, Inc. | 2015-07-02 |
| K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | Gold Standard Diagnostics | 2014-02-28 |
| K120625 | ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV | Roche Diagnostics | 2012-07-25 |
| K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | Bio-Rad Laboratories | 2012-06-22 |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-04-26 |
| K090409 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2009-05-08 |
| K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG | DiaSorin, Inc. | 2008-11-18 |
| K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2008-05-30 |
| K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G | Focus Diagnostics, Inc. | 2007-10-05 |
| K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 | Focus Diagnostics, Inc. | 2007-09-24 |
| K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G | Focus Diagnostics, Inc. | 2007-02-01 |
| K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | 2004-07-13 |
| K021486 | HERPESELECT 2 ELISA IGG, MODEL ELO920G | Focus Technologies, Inc. | 2002-08-01 |
| K021429 | HERPESELECT 1 ELISA IGG, MODEL EL0910G | Focus Technologies, Inc. | 2002-07-29 |
| K993754 | HSV-1 ELISA IGG, MODEL EL0910G | Mrl Diagnostics | 2000-02-09 |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | Meridian Diagnostics, Inc. | 1999-06-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870024332 | HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B) | MONOBIND, INC. | 2024-09-13 |
| 00816870024363 | HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B) | MONOBIND, INC. | 2024-09-13 |
| 00816870024370 | HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B) | MONOBIND, INC. | 2024-09-13 |
| 00380740197704 | Alinity | Abbott Ireland Diagnostics | 2024-05-14 |
| 00380740213879 | Alinity | Abbott Ireland Diagnostics | 2024-05-14 |
| 00380740213886 | Alinity | Abbott Ireland Diagnostics | 2024-05-14 |
| 00850054026095 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-27 |
| 07613336170656 | Elecsys HSV-1 IgG | Roche Diagnostics GmbH | 2022-12-06 |
| 07613336170663 | Elecsys HSV-1 IgG | Roche Diagnostics GmbH | 2022-12-06 |
| 00842768022784 | Atellica IM Herpes-1 IgG | Siemens Healthcare Diagnostics Inc. | 2022-10-28 |
| 03610522051076 | Bio-Rad | Bio-RAD Laboratories, Inc. | 2019-05-28 |
| 00630414016740 | ADVIA Centaur Herpes-1 IgG | Siemens Healthcare Diagnostics Inc. | 2019-04-09 |
| 10816101022301 | DxSelect™ - Stop Reagent | DIASORIN MOLECULAR LLC | 2017-07-11 |
| 10816101022387 | HerpeSelect ELISA Sample Diluent | DIASORIN MOLECULAR LLC | 2017-07-11 |
| 10816101022363 | HSV-1 IgG Antigen Wells | DIASORIN MOLECULAR LLC | 2017-07-11 |
| 10816101022356 | DxSelect™ - 10X Wash Buffer | DIASORIN MOLECULAR LLC | 2017-07-11 |
| 10816101022295 | DxSelect™ - Substrate Reagent | DIASORIN MOLECULAR LLC | 2017-07-11 |
| 04015630940431 | Elecsys HSV-1 IgG | Roche Diagnostics GmbH | 2017-04-21 |
| 08056771600248 | LIAISON® Control HSV-1 IgG | Diasorin Inc. | 2016-09-24 |
| 08056771600231 | LIAISON® HSV-1 Type Specific IgG | Diasorin Inc. | 2016-09-24 |
| 10816101022097 | HSV-1 ELISA IgG High Positive Control | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022226 | DxSelect™ Sample Diluent | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022202 | HSV Serum Panel | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022165 | HSV-1 ELISA IgG Conjugate | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022103 | HSV-1 ELISA IgG Low Positive Control | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022080 | HSV ELISA Negative Control | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022073 | HSV-1 ELISA IgG Cutoff Calibrator | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 04015630939046 | Elecsys HSV1 IgG Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 00847865002172 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010993 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |