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510(k) K081687

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG by DiaSorin, Inc. — Product Code MYF

K081687 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG". The FDA issued a decision of Substantially Equivalent on November 10, 2008. 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. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2008
Date Received
June 17, 2008
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 DiaSorin, Inc.

  • K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (June 4, 2026)
  • DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (December 23, 2025)
  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set (July 14, 2022)
  • K193650 — LIAISON Ferritin (September 14, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)

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)
  • K061239 — EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (June 28, 2007)
  • 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