FDA.reportPublic FDA data

EUROIMMUN US INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30071187473007118747EUROIMMUN US INC.1Y2026-01-011 Bloomfield Ave Mountain Lakes NJ US 07046

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
876351148110273K991998GAMMA-B 25-HYDROXY VITAMIN D RIAMRG1999-09-17
876351706924744K990843SERUM CROSSLAPS ONE STEP ELISAJMM1999-07-09
876351515722867K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYCIN1997-09-11
876351033328157K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaLLL2026-08-21
876352062376084K240865IDS-iSYS Free TestosteroneCDZ2024-10-23
876351303511635K223867IDS ACTH IICKG2023-08-18
876352004009799K202136IDS CortisolCGR2021-04-13
876351669738857K200475IDS-iSYS Ostase BAPCIN2020-09-30
876351620397044K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG2020-09-17
876352065332792K190121IDS SHBGCDZ2019-06-17
876351063168499K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)MVM2019-02-28
876351348598289K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR2017-12-10
876351843261438K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternMOB2018-05-24
876351590336711K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL2018-04-20
876352035554927K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL2018-04-20
876351581329107K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG2016-11-15
876351059530722K161513Anti-Borrelia burgdorferi US Westernblot (IgG)LSR2016-08-25
876351121093162K161158IDS-iSYS Intact PTHNCEW2017-01-31
876351250435793K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX2016-05-17
876351721855684K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP2016-08-12
876351893582162K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP2016-08-10
876351382935503K143324IDS-iSYS CTX-I Calibration VerifiersJJX2015-03-30
876351974382908K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersCJM2015-04-21
876351650526960K14235125-Hydroxy Vitamin Ds EIAMRG2015-08-25
876351441807079K142038EUROIMMUN LYME ELISA(IgG/IgM)LSR2015-05-04
876351314793279K140224EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)LKO2014-12-09
876351756554013K132195EUROIMMUN ANTI-PLA2R ELISA (IGG)PGV2014-06-27
876351961560932K131185ANA SCREEN ELISA (IGG)LJM2013-07-15
876351231112279K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSCIB2013-12-24
876351972083746K12366025-OH VITAMIN D ELISAMRG2013-07-17
876351499893015K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)LKO2013-06-12
876351776067259K123253IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN DMRG2013-06-18
876351049240504K122141IDS-ISYS IGF-I CALIBRATION VERIFIERSJJX2012-08-07
876351270490331K113439EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)NIY2013-04-12
876351417789227K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)LLL2013-04-09
876351488777132K112223EUROIMMUN ANTI-LKM-1 ELISA(LGG)NBS2012-09-11
876351503462516K112221EUROIMMUN ANTI-SLA/LP ELISA(LGG)NIY2012-09-11
876351273727108K111938IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...JJX2012-02-14
876351245518061K111650IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...JJX2011-09-06
876351202758654K110412IDS-ISYS IFG-I CONTROL SETJJX2011-03-16
876351708181141K103325IDS-ISYS INTACT PTHCEW2012-02-03
876351887635074K100017EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEMOSK2010-09-13
876351295490601K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)DBM2010-09-02
876351081076887K091969EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)NBO2010-09-02
876351686655376K091849IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SETMRG2010-06-25
876351955767278K083850EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMSMOB2009-05-20
876351919993409K083615EUROIMMUN ANTI BP 180-4X ELISA (IGG)OEG2009-03-16
876351603771333K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)LRM2009-04-15
876351630514480K083053EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)MST2009-08-07
876351142269319K083052EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)MST2009-07-28
876351576572567K082130EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)MOB2009-04-07
876351718801127K070789EUROIMMUN ANTI-CCP ELISANHX2007-12-31
876351838239690K070763EUROIMMUN ANA IFA: HEP-20-10DHN2007-05-22
876351651084711K061408EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KITMVM2006-10-05
876351278644904K061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KITMYF2007-06-28
876351155651849K060700EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.MOB2006-09-08
876351152162647K051489EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUMMOB2006-02-16
876351352892927K0511101,25-DIHYDROXY VITAMIN D EIAMRG2005-07-06
876351323255843K042519GAMMA-B 1,25-DIHYDROXY VITAMIN DMRG2004-12-01
876351765628982K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITCDZ2003-08-18
876351230660859K014120TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)CDZ2002-02-08
876351860000343K003609N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000NEO2001-05-16
876351367984659DEN140002EUROIMMUN ANTI-PLA2R IFAPGV2014-05-29
876351000038275
876351128676764
876351243058265
876351484502783
876351686832420
876351725723347
876351727973867
876351796705487
876351834337406
876351890135623
876351970276713
876351989710309
876352035783008
876351038995333
876351047177577
876351050557552
876351063720460
876351070876946
876351091121455
876351106704169
876351147609127
876351176076471
876351188584201
876351196123722
876351223820795
876351248411688
876351263934562
876351298988046
876351302601840
876351311678048
876351322059757
876351380812340
876351383189954
876351393641325
876351409542802
876351473985691
876351511475604
876351528336577
876351578949800
876351584471005
876351595793663
876351648066788
876351686478184
876351688103439
876351695634387
876351733532438
876351755447468
876351765867558
876351848217317
876351875900381
876351940313573
876351955090733
876351969492305
876351975510074
876351988370121
876352017624603
876352033964446

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MRG82016-11-15
JJX62016-05-17
MOB52018-05-24
CDZ42024-10-23
LSR32017-12-10
LLL22026-08-21
CIN22020-09-30
OEG22020-09-17
MVM22019-02-28
KTL22018-04-20
CEW22017-01-31
NOP22016-08-12
LKO22014-12-09
PGV22014-06-27
NIY22013-04-12
MST22009-08-07
CKG12023-08-18
CGR12021-04-13
CJM12015-04-21
CIB12013-12-24
LJM12013-07-15
NBS12012-09-11
OSK12010-09-13
NBO12010-09-02
DBM12010-09-02
LRM12009-04-15
NHX12007-12-31
MYF12007-06-28
DHN12007-05-22
NEO12001-05-16
JMM11999-07-09