Data / Medical devices / United States / Euroimmun Us Inc.
Euroimmun Us Inc.: FDA-registered device maker in Mountain Lakes, NJ, United States, 62 510(k) clearances
Euroimmun Us Inc. is registered with the FDA (registration 3007118747) in Mountain Lakes, NJ, United States. It lists 78 device types. The FDA files 62 510(k) clearances under its listings, the newest dated August 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007118747
- Address
- 1 Bloomfield Ave, Mountain Lakes, NJ, United States, 07046
- Owner or operator
- EUROIMMUN US Inc. (10025673)
- Roles
- Complaint file establishment, Contract manufacturer
- First device listed
- June 6, 2008
- Registered through
- 2026
- Brand names listed
- 1,25-Dihydroxy Vitamin D EIA, 1,25-Dihydroxy Vitamin D RIA, 17-OH Progesterone ELISA, 25-Hydroxy Vitamin D RIA, 25-Hydroxy Vitamin DS EIA, 25-OH Vitamin D ELISA, ANA IFA: HEp-20-10, ANA Screen ELISA (IgG) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | LLL | Substantially Equivalent | Immunodiagnostics Systems Limited | accessdata.fda.gov |
| October 23, 2024 | K240865 | IDS-iSYS Free Testosterone | CDZ | Substantially Equivalent | Immunodiagnostic Systems Limited | accessdata.fda.gov |
| August 18, 2023 | K223867 | IDS ACTH II | CKG | Substantially Equivalent | Immunodiagnostic Systems Limited | accessdata.fda.gov |
| April 13, 2021 | K202136 | IDS Cortisol | CGR | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| September 30, 2020 | K200475 | IDS-iSYS Ostase BAP | CIN | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| September 17, 2020 | K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | OEG | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| June 17, 2019 | K190121 | IDS SHBG | CDZ | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| February 28, 2019 | K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | MVM | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| May 24, 2018 | K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | MOB | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| April 20, 2018 | K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | KTL | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| April 20, 2018 | K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | KTL | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| December 10, 2017 | K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | LSR | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| January 31, 2017 | K161158 | IDS-iSYS Intact PTHN | CEW | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| November 15, 2016 | K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| August 25, 2016 | K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | LSR | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| August 12, 2016 | K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | NOP | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| August 10, 2016 | K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | NOP | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| May 17, 2016 | K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| August 25, 2015 | K142351 | 25-Hydroxy Vitamin Ds EIA | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| May 4, 2015 | K142038 | EUROIMMUN LYME ELISA(IgG/IgM) | LSR | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| April 21, 2015 | K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | CJM | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| March 30, 2015 | K143324 | IDS-iSYS CTX-I Calibration Verifiers | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| December 9, 2014 | K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | LKO | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| June 27, 2014 | K132195 | EUROIMMUN ANTI-PLA2R ELISA (IGG) | PGV | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| May 29, 2014 | DEN140002 | EUROIMMUN ANTI-PLA2R IFA | PGV | Unknown | Euroimmun US | accessdata.fda.gov |
| December 24, 2013 | K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | CIB | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| July 17, 2013 | K123660 | 25-OH VITAMIN D ELISA | MRG | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| July 15, 2013 | K131185 | ANA SCREEN ELISA (IGG) | LJM | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| June 18, 2013 | K123253 | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| June 12, 2013 | K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | LKO | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| April 12, 2013 | K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | NIY | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| April 9, 2013 | K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | LLL | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| September 11, 2012 | K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | NBS | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| September 11, 2012 | K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | NIY | Substantially Equivalent | Euroimmun US | accessdata.fda.gov |
| August 7, 2012 | K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| February 14, 2012 | K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| February 3, 2012 | K103325 | IDS-ISYS INTACT PTH | CEW | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| September 6, 2011 | K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| March 16, 2011 | K110412 | IDS-ISYS IFG-I CONTROL SET | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| September 13, 2010 | K100017 | EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM | OSK | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| September 2, 2010 | K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) | DBM | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| September 2, 2010 | K091969 | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) | NBO | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| June 25, 2010 | K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET | MRG | Substantially Equivalent | Immunodiagnostic Systems, Inc. | accessdata.fda.gov |
| August 7, 2009 | K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) | MST | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| July 28, 2009 | K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) | MST | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| May 20, 2009 | K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | MOB | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| April 15, 2009 | K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) | LRM | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| April 7, 2009 | K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | MOB | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| March 16, 2009 | K083615 | EUROIMMUN ANTI BP 180-4X ELISA (IGG) | OEG | Substantially Equivalent | Euroimmun Us, Inc. | accessdata.fda.gov |
| December 31, 2007 | K070789 | EUROIMMUN ANTI-CCP ELISA | NHX | Substantially Equivalent | Euroimmun Us, LLC | accessdata.fda.gov |
| May 22, 2007 | K070763 | EUROIMMUN ANA IFA: HEP-20-10 | DHN | Substantially Equivalent | Euroimmun Us, LLC | accessdata.fda.gov |
| October 5, 2006 | K061408 | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT | MVM | Substantially Equivalent | Euroimmun Us, LLC | accessdata.fda.gov |
| September 8, 2006 | K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | MOB | Substantially Equivalent | Euroimmun Us, LLC | accessdata.fda.gov |
| February 16, 2006 | K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM | MOB | Substantially Equivalent | Euroimmun Us, LLC | accessdata.fda.gov |
| July 6, 2005 | K051110 | 1,25-DIHYDROXY VITAMIN D EIA | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| December 1, 2004 | K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| August 18, 2003 | K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | CDZ | Substantially Equivalent | Diagnostics Biochem Canada, Inc. | accessdata.fda.gov |
| February 8, 2002 | K014120 | TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) | CDZ | Substantially Equivalent | Diagnostics Biochem Canada, Inc. | accessdata.fda.gov |
| May 16, 2001 | K003609 | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | NEO | Substantially Equivalent | Osteometer Biotech A/S | accessdata.fda.gov |
| September 17, 1999 | K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA | MRG | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| July 9, 1999 | K990843 | SERUM CROSSLAPS ONE STEP ELISA | JMM | Substantially Equivalent | Osteometer Biotech A/S | accessdata.fda.gov |
| September 11, 1997 | K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | CIN | Substantially Equivalent | Hybritech, Inc. | accessdata.fda.gov |
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Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.