FDA.reportPublic FDA data

PHADIA US INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049734083004973408PHADIA US INC.1Y2026-01-014169 COMMERCIAL AVE. Portage MI US 49002

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
131221385941974K901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDELSR1990-04-05
131222072973929K894625CHLAMYDIA (LGV-1)LKI1989-08-15
131221532632724K894624MUMPS VIRUSGRA1989-10-16
131221969922485K894623RESPIRATORY SYNCYTIAL VIRUSLKT1989-10-16
131221274412696K894622VARICELLA ZOSTER VIRUSGQW1989-10-24
131221755092308K893240BION EBV-M (VCA) TEST SYSTEMLJN1989-07-14
131221887519959K891785BION EBV-G (VCA) TEST SYSTEMJRY1989-08-31
131221943908480K890616BION DIRECT IDENTIFICATION CONTROL SLIDELJG1989-02-17
131221690814173K881261BION HSV1-G OR HSV2-G TEST SYSTEMGQO1988-06-07
131221579801874K880679BION CMV-G TEST SYSTEMGQH1988-06-03
131221156180781K872845BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUMDHN1987-08-17
131221974005002K212181ImmunoCAP 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
131221731647389K210902EliA Ro52, EliA Ro60LKJ2022-07-27
131221793739518K202541EliA RNA Pol IIINYO2021-09-13
131221818224760K202540EliA Rib-PMQA2021-09-13
131221874174292K202067EliA SmDP-SLKP2021-07-14
131221765770807K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineDHB2020-05-01
131221530324973K190710EliA SymphonyS ImmunoassayLLL2019-11-29
131221387335863K190315ImmunoCAP 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
131221604463583K182747EliA RF IgM ImmunoassayDHR2018-12-18
131221722963532K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB2018-03-13
131221117214619K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutDHB2018-04-16
131221200921050K173704ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control StripOYL2018-03-02
131221552429855K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB2018-03-23
131221086754508K172348AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10LSW2018-02-16
131221336970610K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEDHB2017-05-05
131221053034119K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMDHN2016-07-28
131221308469178K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000JZO2016-03-25
131221053797642K150854ImmunoCAP 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
131221372936669K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust miteDHB2016-02-29
131221120888148K141375ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250DBM2015-02-13
131221863954412K140493ELIA SCL-70S IMMUNOASSAYLJM2014-10-30
131221163394633K140225ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POMOB2014-10-27
131221320538430K133404IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMHDGC2014-02-24
131221066749920K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYMID2013-12-23
131221770480736K131738IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL HDHB2013-07-10
131221832796162K123275IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOMDHB2013-06-28
131221108868564K122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESDHB2013-08-28
131221645117080K121463IMMUNOCAP ALLERGEN K82DHB2013-01-29
131221668492328K121156AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESDHB2013-03-13
131221271863035K113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEDHB2012-09-13
131221340514182K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYMSV2012-06-22
131221449198769K111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSDHB2011-12-22
131221282653063K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMDHR2011-09-30
131221762348878K101251IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGENDHB2011-05-27
131221972427399K100999IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01DHB2010-12-15
131222002964162K093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01MST2010-08-13
131221029958563K092050IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01DHB2009-11-20
131221684629199K091845CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEMMID2010-06-07
131221535846831K083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01LKO2009-05-28
131221248511631K082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYLKJ2009-04-10
131221432383255K072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01LSW2007-12-07
131221372853389K071913IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01DHB2007-08-24
131221312633379K063775ELIA GLIADIN IGA, IGG AND CELIAC CONTROLMST2007-03-14
131221971908383K062787ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01MVM2006-12-29
131221939599970K062583ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01MVM2006-12-26
131221277463586K061165ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01NHX2006-08-03
131222017266310K051218MODIFICATION TO: UNICAP SPECIFIC IGEDHB2005-06-09
131221931752834DEN120001IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASEOYL2012-02-15
131221130860963
131221230400537
131221324324600
131221328274692
131221342040593
131221477887604
131221565903091
131221590274360
131221633127155
131221641679748
131221743334110
131221756568503
131221852994509
131221861422347
131221891281258
131221968245242
131221972810002
131222004166831

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DHB192022-08-03
MOB32018-03-23
LKJ22022-07-27
DHR22018-12-18
OYL22018-03-02
LSW22018-02-16
DHN22016-07-28
MID22013-12-23
MST22010-08-13
MVM22006-12-29
MQA12021-09-13
NYO12021-09-13
LKP12021-07-14
LLL12019-11-29
JZO12016-03-25
DBM12015-02-13
LJM12014-10-30
DGC12014-02-24
MSV12012-06-22
LKO12009-05-28
NHX12006-08-03
LSR11990-04-05
GQW11989-10-24
GRA11989-10-16
LKT11989-10-16
JRY11989-08-31
LKI11989-08-15
LJN11989-07-14
LJG11989-02-17
GQO11988-06-07
GQH11988-06-03

PMN#