Product code MXJ— Microbiology
ADVIA Centaur Herpes-1 IgG
- Classification name
- Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code MXJ
FDA has cleared devices under product code MXJ between 1999 and 2023, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2022
- 2018
- 2016
- 2015
- 2014
- 2012
- 2011
- 2009
- 2008
- 2007
- 2004
- 2002
- 2000
- 1999
Top applicants under product code MXJ
Adverse events under product code MXJ
product code MXJ- Injury
- 139
- Total
- 139
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MXJ
- K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
- K220923 — Elecsys HSV-1 IgG (08948844160)
- K181333 — ADVIA Centaur Herpes-1 IgG
- K162276 — SeraQuest Herpes Type 1 Specific IgG
- K143236 — Theranos Herpes Simplex Virus-1 IgG Assay
- K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
- K120625 — ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
- K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
- K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM
- K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K081685 — LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
- K072178 — ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
- K071511 — PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
- K071510 — HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
- K062543 — HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
- K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
- K021486 — HERPESELECT 2 ELISA IGG, MODEL ELO920G
- K021429 — HERPESELECT 1 ELISA IGG, MODEL EL0910G
- K993754 — HSV-1 ELISA IGG, MODEL EL0910G
- K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.