Product code MYF
- Device name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- 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 |
|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. | 2025-02-12 |
| K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | 2022-10-12 |
| K181514 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | 2019-06-13 |
| K181334 | ADVIA Centaur Herpes-2 IgG | Biokit, S.A. | 2018-08-23 |
| K152353 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | 2016-05-13 |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-05-20 |
| K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | DiaSorin, Inc. | 2008-11-10 |
| K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT | Euroimmun Us, LLC | 2007-06-28 |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | 2004-07-13 |
| K993724 | HSV-2 ELISA IGG, MODEL EL0920G | Mrl Diagnostics | 2000-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740213893 | Alinity | Abbott Ireland Diagnostics | 2025-10-14 |
| 00380740213909 | Alinity | Abbott Ireland Diagnostics | 2025-10-14 |
| 00380740197742 | Alinity | Abbott Ireland Diagnostics | 2025-10-14 |
| 00850054026088 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-27 |
| 07613336170694 | Elecsys HSV-2 IgG | Roche Diagnostics GmbH | 2022-12-06 |
| 07613336170687 | Elecsys HSV-2 IgG | Roche Diagnostics GmbH | 2022-12-06 |
| 00842768022807 | Atellica IM Herpes-2 IgG | Siemens Healthcare Diagnostics Inc. | 2022-10-28 |
| 03610522051236 | Bio-Rad | Bio-RAD Laboratories, Inc. | 2019-05-28 |
| 00630414016726 | ADVIA Centaur Herpes-2 IgG | Siemens Healthcare Diagnostics Inc. | 2019-04-09 |
| 10816101022370 | HSV-2 IgG Antigen Wells | DIASORIN MOLECULAR LLC | 2017-07-11 |
| 04015630940448 | Elecsys HSV-2 IgG | Roche Diagnostics GmbH | 2017-04-21 |
| 04049016096733 | Anti-HSV-2 (gG2) ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 08056771600101 | LIAISON® HSV-2 Type Specific IgG | Diasorin Inc. | 2016-09-24 |
| 05391516747059 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05391516743518 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 05391516743501 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 10816101022172 | HSV-2 ELISA IgG Conjugate | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022134 | HSV-2 ELISA IgG Low Positive Control | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022127 | HSV-2 ELISA IgG High Positive Control | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 10816101022110 | HSV-2 ELISA IgG Cutoff Calibrator | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 20816101022186 | HerpeSelect® 2 ELISA IgG | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 20816101022193 | HerpeSelect® 2 ELISA IgG | DIASORIN MOLECULAR LLC | 2016-09-22 |
| 05391516743327 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-21 |
| 05391516746939 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-21 |
| 04015630939053 | Elecsys HSV2 IgG Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 00847865002172 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000949 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010993 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865004725 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002479 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |