MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Class II
FDA Device Classification
Classification Details
- Product Code
- MXJ
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K213987 | biokit | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control | September 20, 2023 |
| K220923 | roche diagnostics | Elecsys HSV-1 IgG (08948844160) | October 12, 2022 |
| K181333 | biokit | ADVIA Centaur Herpes-1 IgG | August 23, 2018 |
| K162276 | quest international | SeraQuest Herpes Type 1 Specific IgG | October 1, 2016 |
| K143236 | theranos | Theranos Herpes Simplex Virus-1 IgG Assay | July 2, 2015 |
| K131334 | gold standard diagnostics | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | February 28, 2014 |
| K120625 | roche diagnostics | ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV | July 25, 2012 |
| K120959 | bio-rad laboratories | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | June 22, 2012 |
| K103363 | zeus scientific | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | April 26, 2011 |
| K090409 | bio-rad laboratories | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYS | May 8, 2009 |
| K081685 | diasorin | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG | November 18, 2008 |
| K072178 | zeus scientific | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | May 30, 2008 |
| K071511 | focus diagnostics | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G | October 5, 2007 |
| K071510 | focus diagnostics | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 | September 24, 2007 |
| K062543 | focus diagnostics | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G | February 1, 2007 |
| K033105 | trinity biotech usa | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | July 13, 2004 |
| K021486 | focus technologies | HERPESELECT 2 ELISA IGG, MODEL ELO920G | August 1, 2002 |
| K021429 | focus technologies | HERPESELECT 1 ELISA IGG, MODEL EL0910G | July 29, 2002 |
| K993754 | mrl diagnostics | HSV-1 ELISA IGG, MODEL EL0910G | February 9, 2000 |
| K984343 | meridian diagnostics | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | June 25, 1999 |