FDA.reportPublic FDA data

Carla Krause

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96105663002807876Carla Krause1N2026-01-014169 Commercial Avenue Portage MI US 49002
30393536463039353646Carla Krause1N2026-01-014169 Commercial Ave Portage MI US 49002

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3410831974005002K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seedDHB2022-08-03
131231974005002K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seedDHB2022-08-03
131231731647389K210902EliA Ro52, EliA Ro60LKJ2022-07-27
131231793739518K202541EliA RNA Pol IIINYO2021-09-13
131231818224760K202540EliA Rib-PMQA2021-09-13
131231874174292K202067EliA SmDP-SLKP2021-07-14
3410831765770807K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineDHB2020-05-01
131231765770807K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineDHB2020-05-01
131231530324973K190710EliA SymphonyS ImmunoassayLLL2019-11-29
131231387335863K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 CatDHB2019-05-14
3410831387335863K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 CatDHB2019-05-14
131231604463583K182747EliA RF IgM ImmunoassayDHR2018-12-18
131231709953064K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM2018-11-27
131231121168599K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayMVM2019-03-01
131231691077480K181556EliA M2 ImmunoassayDBM2018-07-13
131231222508963K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayMSV2018-06-25
131231722963532K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB2018-03-13
131231117214619K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutDHB2018-04-16
131231200921050K173704ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control StripOYL2018-03-02
131231336970610K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEDHB2017-05-05
3410831336970610K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEDHB2017-05-05
3410831308469178K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000JZO2016-03-25
131231308469178K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000JZO2016-03-25
131231761364302K151029Phadia PrimeDHB2016-01-19
3410831053797642K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nutDHB2015-12-14
131231053797642K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nutDHB2015-12-14
3410831372936669K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust miteDHB2016-02-29
131231372936669K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust miteDHB2016-02-29
131231120888148K141375ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250DBM2015-02-13
131231863954412K140493ELIA SCL-70S IMMUNOASSAYLJM2014-10-30
131231163394633K140225ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POMOB2014-10-27
3410831163394633K140225ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POMOB2014-10-27
131231320538430K133404IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMHDGC2014-02-24
131231354864295K132631EIA SMDP IMMUNOASSAYLKP2014-08-29
131231066749920K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYMID2013-12-23
3410831770480736K131738IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL HDHB2013-07-10
131231770480736K131738IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL HDHB2013-07-10
131231832796162K123275IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOMDHB2013-06-28
3410831832796162K123275IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOMDHB2013-06-28
3410831108868564K122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESDHB2013-08-28
131231108868564K122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESDHB2013-08-28
3410831645117080K121463IMMUNOCAP ALLERGEN K82DHB2013-01-29
131231645117080K121463IMMUNOCAP ALLERGEN K82DHB2013-01-29
131231668492328K121156AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESDHB2013-03-13
3410831668492328K121156AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESDHB2013-03-13
131231271863035K113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEDHB2012-09-13
3410831271863035K113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEDHB2012-09-13
131231340514182K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYMSV2012-06-22
131231449198769K111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSDHB2011-12-22
3410831449198769K111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSDHB2011-12-22
131231282653063K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMDHR2011-09-30
131231762348878K101251IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGENDHB2011-05-27
3410831762348878K101251IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGENDHB2011-05-27
131231972427399K100999IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01DHB2010-12-15
3410831972427399K100999IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01DHB2010-12-15
131232002964162K093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01MST2010-08-13
131231029958563K092050IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01DHB2009-11-20
3410831029958563K092050IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01DHB2009-11-20
131231684629199K091845CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEMMID2010-06-07
3410831684629199K091845CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEMMID2010-06-07
131231535846831K083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01LKO2009-05-28
131231248511631K082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYLKJ2009-04-10
131231375755337K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPJNL2007-11-20
131231432383255K072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01LSW2007-12-07
3410831432383255K072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01LSW2007-12-07
131231610201299K072149ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01LLL2008-01-15
131231372853389K071913IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01DHB2007-08-24
3410831372853389K071913IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01DHB2007-08-24
131231312633379K063775ELIA GLIADIN IGA, IGG AND CELIAC CONTROLMST2007-03-14
131231971908383K062787ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01MVM2006-12-29
131231939599970K062583ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01MVM2006-12-26
131231277463586K061165ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01NHX2006-08-03
3410831277463586K061165ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01NHX2006-08-03
131231791964410K052793IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02MST2006-02-07
3410832017266310K051218MODIFICATION TO: UNICAP SPECIFIC IGEDHB2005-06-09
131232017266310K051218MODIFICATION TO: UNICAP SPECIFIC IGEDHB2005-06-09
131231931752834DEN120001IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASEOYL2012-02-15
3410831066749920
131231130860963
3410831130860963
131231230400537
3410831248511631
3410831340514182
131231342040593
3410831342040593
131231477887604
3410831530324973
3410831535846831
131231565903091
131231590274360
3410831590274360
3410831641679748
131231641679748
3410831731647389
131231756568503
3410831793739518
3410831818224760
3410831863954412
3410831874174292

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DHB382022-08-03
MVM32019-03-01
MOB32018-03-13
MID32013-12-23
MST32010-08-13
LKJ22022-07-27
LKP22021-07-14
LLL22019-11-29
DHR22018-12-18
LJM22018-11-27
DBM22018-07-13
MSV22018-06-25
OYL22018-03-02
JZO22016-03-25
LSW22007-12-07
NHX22006-08-03
NYO12021-09-13
MQA12021-09-13
DGC12014-02-24
LKO12009-05-28
JNL12007-11-20