Herpes Simplex Virus Type 1 Igg Elisa Test
FDA 510(k) K131334 · Gold Standard Diagnostics
510(k) numberK131334
Submission
- Device name
- Herpes Simplex Virus Type 1 Igg Elisa Test
- Applicant
- Gold Standard Diagnostics
Davis, CA, US - Received
- May 9, 2013
- Decision date
- February 28, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code MXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | Biokit, S.A. | 09/20/2023SE |
| K220923 | Elecsys HSV-1 IgG (08948844160)MXJ · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | Biokit, S.A. | 08/23/2018SE |
| K162276 | SeraQuest Herpes Type 1 Specific IgGMXJ · Traditional | Quest International, Inc. | 10/01/2016SE |
| K143236 | Theranos Herpes Simplex Virus-1 IgG AssayMXJ · Traditional | Theranos, Inc. | 07/02/2015SE |
| K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVMXJ · Traditional | Roche Diagnostics | 07/25/2012SE |
| K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg KitMXJ · Traditional | Bio-Rad Laboratories | 06/22/2012SE |
| K103363 | Zeus Elisa HSV Gc-I Igg Test SystemMXJ · Traditional | Zeus Scientific, Inc. | 04/26/2011SE |
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemMXJ · Traditional | Bio-Rad Laboratories | 05/08/2009SE |
| K081685 | Liaison HSV-1 Type Specific Igg Assay, Control HSV-1 IggMXJ · Traditional | DiaSorin, Inc. | 11/18/2008SE |
More from DiaSorin, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | 10/10/2025SE |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | 05/02/2018SE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | 11/12/2015SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | 01/28/2014SE |
Questions and answers
When was Herpes Simplex Virus Type 1 Igg Elisa Test cleared by the FDA?
Herpes Simplex Virus Type 1 Igg Elisa Test (K131334) received a 510(k) decision of Substantially Equivalent on February 28, 2014, 295 days after the submission was received.
What is the product code of K131334?
The FDA product code is MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, a Class II (moderate risk) device regulated under 21 CFR 866.3305.