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510(k) K153308

EUROIMMUN Anti-West Nile Virus ELISA (IgM) by Euroimmun Us, Inc. — Product Code NOP

K153308 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN Anti-West Nile Virus ELISA (IgM)". The FDA issued a decision of Substantially Equivalent on August 12, 2016. The device falls under product code NOP (Elisa, Antibody, West Nile Virus), a Class II device regulated under 21 CFR 866.3940. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2016
Date Received
November 17, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elisa, Antibody, West Nile Virus
Device Class
Class II
Regulation Number
866.3940
Review Panel
MI
Submission Type

The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.

Other clearances by Euroimmun Us, Inc.

  • 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)
  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 2016)
  • K142038 — EUROIMMUN LYME ELISA(IgG/IgM) (May 4, 2015)
  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)

Other clearances for product code NOP

  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 2016)
  • K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST (November 30, 2006)
  • K041817 — WEST NILE DETECT IGM ELISA (November 19, 2004)
  • K041068 — WEST NILE VIRUS IGG INDIRECT ELISA (October 20, 2004)
  • K041231 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (August 10, 2004)
  • K040854 — WEST NILE VIRUS IGM CAPTURE ELISA (June 30, 2004)
  • K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G (October 22, 2003)
  • K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (October 22, 2003)
  • DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)

FDA data resources