FDA.reportPublic FDA data

Faith Du

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30073615133007361513Faith Du1N2027-01-011 BLOOMFIELD AVENUE Mountain Lakes NJ US 07046
96157773007034602Faith Du1N2026-01-011 Bloomfield Avenue Mountain Lakes Mountain Lakes NJ US 07046

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1877751206129385K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG2020-09-17
1877751060943553K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)MVM2019-02-28
1877751512232707K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR2017-12-10
1877752021103496K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternMOB2018-05-24
1877751616410446K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL2018-04-20
1877751595456158K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL2018-04-20
1109781492641294K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetMRG2016-11-15
1877751087555383K161513Anti-Borrelia burgdorferi US Westernblot (IgG)LSR2016-08-25
1877751829254931K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP2016-08-12
1877751572014357K153303EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP2016-08-10
1877751546275921K142038EUROIMMUN LYME ELISA(IgG/IgM)LSR2015-05-04
1877751325588838K141827EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWAREDHN2015-04-17
1877752004452441K140224EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)LKO2014-12-09
1877751235304879K132195EUROIMMUN ANTI-PLA2R ELISA (IGG)PGV2014-06-27
1877751156507727K131791IFA 40: HEP-20-10DHN2014-02-26
1877751349024882K131185ANA SCREEN ELISA (IGG)LJM2013-07-15
1877751159021132K12366025-OH VITAMIN D ELISAMRG2013-07-17
1877751070201999K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)LKO2013-06-12
1877751548588262K113439EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)NIY2013-04-12
1877751257467564K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)LLL2013-04-09
1877752030135481K112223EUROIMMUN ANTI-LKM-1 ELISA(LGG)NBS2012-09-11
1877751679805790K112221EUROIMMUN ANTI-SLA/LP ELISA(LGG)NIY2012-09-11
1877751880777507K100017EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEMOSK2010-09-13
1877751963522425K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)DBM2010-09-02
1877751632345559K091969EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)NBO2010-09-02
1109781715850133K091849IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SETMRG2010-06-25
1877751567668031K083850EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMSMOB2009-05-20
1877751056420647K083615EUROIMMUN ANTI BP 180-4X ELISA (IGG)OEG2009-03-16
1877751670960453K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)LRM2009-04-15
1877751110211827K083053EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)MST2009-08-07
1877751046840169K083052EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)MST2009-07-28
1877751909048650K082130EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)MOB2009-04-07
1877751799075123K070789EUROIMMUN ANTI-CCP ELISANHX2007-12-31
1877751307470021K070763EUROIMMUN ANA IFA: HEP-20-10DHN2007-05-22
1877751763374730K061408EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KITMVM2006-10-05
1877751167035948K061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KITMYF2007-06-28
1877751920425418K060700EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.MOB2006-09-08
1877751431171620K051489EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUMMOB2006-02-16
1877751669638176K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITCDZ2003-08-18
1877751608579198DEN140002EUROIMMUN ANTI-PLA2R IFAPGV2014-05-29
1109781167610455
1877751308418266
1877751365221656
1877751592411769
1877751687095228
1877751755855126
1877751780250305
1877751869029985
1877751873422768
1877751883793899
1877751887909064
1877751903033728
1877751991909001
1877752050895549
1877751051692060
1877751061804669
1877751223969465
1877751236001419
1877751238015891
1877751310782251
1877751320427024
1877751324938835
1877751334746140
1877751343411280
1877751356706949
1877751370620920
1877751375355634
1877751376274743
1877751405669322
1877751425949138
1877751426198948
1877751455169986
1877751492997338
1877751554832411
1877751574369185
1877751611047909
1877751631857296
1877751633298632
1877751696709319
1877751786055736
1877751818701165
1877751836028646
1877751858200756
1877751933289516
1877751945030667
1877751961557597

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOB52018-05-24
LSR32017-12-10
MRG32016-11-15
DHN32015-04-17
OEG22020-09-17
MVM22019-02-28
KTL22018-04-20
NOP22016-08-12
LKO22014-12-09
PGV22014-06-27
NIY22013-04-12
MST22009-08-07
LJM12013-07-15
LLL12013-04-09
NBS12012-09-11
OSK12010-09-13
NBO12010-09-02
DBM12010-09-02
LRM12009-04-15
NHX12007-12-31
MYF12007-06-28
CDZ12003-08-18