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510(k) K181514

SeraQuest HSV Type 2 Specific IgG by Quest International, Inc. — Product Code MYF

K181514 is an FDA 510(k) premarket notification submitted by Quest International, Inc. for the device "SeraQuest HSV Type 2 Specific IgG". The FDA issued a decision of Substantially Equivalent on June 13, 2019. 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. Quest International, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2019
Date Received
June 8, 2018
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 Quest International, Inc.

  • K162276 — SeraQuest Herpes Type 1 Specific IgG (October 1, 2016)
  • K152353 — SeraQuest HSV Type 2 Specific IgG (May 13, 2016)

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)
  • 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)

FDA data resources