Euroimmun Anti-PLA2R Ifa

No FDA recalls on record, checked 11 Oct 2026.

De Novo Number

DEN140002 ↗

FDA Product Code

PGV

Device Class

Class II

Regulation

21 CFR Part 866.5780

Advisory Committee

Microbiology

FDA Decision

DENG De Novo granted

• 25-Oh Vitamin D Elisa

  Class II

  FDA 510(k) K123660 Active Cleared 17 Jul 2013

• EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

  Class II

  FDA 510(k) K172582 Active Cleared 24 May 2018

• Euroimmun Anti-M2-3E Elisa (Igg)

  Class II

  FDA 510(k) K092736 Active Cleared 2 Sep 2010

• Euroimmun Anti-Gliadin (Gaf-3X) Elisa (Iga)

  Class II

  FDA 510(k) K083052 Active Cleared 28 Jul 2009

• Euroimmun Anti Bp 180-4X Elisa (Igg)

  Class II

  FDA 510(k) K083615 Active Cleared 16 Mar 2009

• Euroimmun Anti-Hsv-2 Elisa (Igg) and Anti-Hsv-1 Elisa (Igg) Kit

  Class II

  FDA 510(k) K061239 Active Cleared 28 Jun 2007

See all devices from Euroimmun Us Inc. →