# Euroimmun Us, Inc.

- Location (FDA's records): Morris Plains, NJ
- FDA decisions: 37 (2006–2020): 36 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Euroimmun Us, Inc. (19); Euroimmun US (12); Euroimmun Us, LLC (6)
- Product codes: MOB (5), DHN (3), LSR (3), OEG (2), NOP (2), MVM (2), LKO (2), MST (2), NIY (2), KTL (2), PGV (2), DBM (1)
- Predicates its devices cite: 25 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Inova Diagnostics, Inc.: 16 (https://510kreport.com/company/inova-diagnostics)
- Focus Technologies, Inc.: 2 (https://510kreport.com/company/focus-technologies)
- Aesku Diagnostics: 2 (https://510kreport.com/company/aesku-diagnostics)
- Immunodiagnostic Systems, Ltd.: 1 (https://510kreport.com/company/immunodiagnostic-systems)
- Immuno Concepts, Inc.: 1 (https://510kreport.com/company/immuno-concepts)

## Firms that cite its devices most
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Its most-cited devices
- K123261: Euroimmun Anti-NRNP/SM Elisa (Igg) (2013), cited by 1
- K123660: 25-OH  Vitamin D Elisa (2013), cited by 1
- DEN140002: Euroimmun Anti-PLA2R Ifa (2014), cited by 1
- K083850: Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems (2009), cited by 1

## Recent decisions
- K193115: EUROIMMUN Anti-BP230-CF ELISA (IgG) (Sep 17, 2020)
- K183313: EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) (Feb 28, 2019)
- K172582: EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern (May 24, 2018)
- K172244: EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (Apr 20, 2018)
- K172252: EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (Apr 20, 2018)
- K172722: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) (Dec 10, 2017)
- K161513: Anti-Borrelia burgdorferi US Westernblot (IgG) (Aug 25, 2016)
- K153308: EUROIMMUN Anti-West Nile Virus ELISA (IgM) (Aug 12, 2016)

Source page: https://510kreport.com/company/euroimmun-us