Home / 510(k) Clearances / K061239

510(k) K061239

EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT by Euroimmun Us, LLC — Product Code MYF

K061239 is an FDA 510(k) premarket notification submitted by Euroimmun Us, LLC for the device "EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT". The FDA issued a decision of Substantially Equivalent on June 28, 2007. The device falls under product code MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2), a Class II device regulated under 21 CFR 866.3305. Euroimmun Us, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2007
Date Received
May 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Euroimmun Us, LLC

  • K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG) (September 17, 2020)
  • K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transg (February 28, 2019)
  • K172582 — EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte (May 24, 2018)
  • K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) (December 10, 2017)
  • K161513 — Anti-Borrelia burgdorferi US Westernblot (IgG) (August 25, 2016)
  • K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM) (August 12, 2016)
  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 2016)
  • K142038 — EUROIMMUN LYME ELISA(IgG/IgM) (May 4, 2015)

Other clearances for product code MYF

  • K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Control (February 12, 2025)
  • K220924 — Elecsys HSV-2 IgG (08948887160) (October 12, 2022)
  • K181514 — SeraQuest HSV Type 2 Specific IgG (June 13, 2019)
  • K181334 — ADVIA Centaur Herpes-2 IgG (August 23, 2018)
  • K152353 — SeraQuest HSV Type 2 Specific IgG (May 13, 2016)
  • K103603 — ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (May 20, 2011)
  • K081687 — LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (November 10, 2008)
  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K993724 — HSV-2 ELISA IGG, MODEL EL0920G (February 1, 2000)

FDA data resources