MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Class II
FDA product code MXJ covers "Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |