Home / 510(k) Clearances / K243575

510(k) K243575

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls by Biokit, S.A. — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2025
Date Received
November 19, 2024
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 Biokit, S.A.

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  • K214068 — Quantia IgE (February 21, 2023)
  • K181334 — ADVIA Centaur Herpes-2 IgG (August 23, 2018)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K152185 — ARCHITECT SHBG (February 11, 2016)
  • K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS (December 19, 2013)
  • K123947 — ARCHITECT IVANCOMYCIN (August 29, 2013)
  • K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D (November 23, 2011)

Other clearances for product code MYF

  • 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)
  • 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)