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510(k) K181334

ADVIA Centaur Herpes-2 IgG by Biokit, S.A. — Product Code MYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2018
Date Received
May 21, 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

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Other clearances for product code MYF

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  • K181514 — SeraQuest HSV Type 2 Specific IgG (June 13, 2019)
  • 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)