FDA.reportPublic FDA data

Marlene Hanna

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30129639433012963943Marlene Hanna1N2026-01-01100 Indigo Creek Dr Rochester NY US 14626

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3126091385088354P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLSSEI2011-07-20
3126091433667431P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLSLOM2011-05-11
3126091909123349P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATORSEI2004-03-04
3126091039148954P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATORSEI2004-03-04
3126091876315254P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORMZO2001-08-30
3126091385779327P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNRLOM2001-04-27
3126092070006446P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORSSEI2000-09-29
3126091343396273K994145VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORSJIS1999-12-22
3126091545196239K983690VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKMOI1999-02-02
3126091721546618K983513VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1998-11-03
3126091757233346K983507VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAYJJY1998-11-04
3126091194774061K974644VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13
3126091796900905K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25
3126091836532856K965142VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)CEC1997-03-18
3126091483979437K964960VITROS CHEMISTRY PRODUCTS UPRO SLIDESJGP1997-02-18
3126091417738613K964721VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)KLI1996-12-18
3126091183794043K964720VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)CGJ1997-02-04
3126091409395610K962919VITROS IMMUNODIAGNOSTIC SYSTEMKHO1996-10-18
3126091939127048K954933EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHENLDP1995-12-18
3126091408645809K953197EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)DCK1995-07-31
3126091109563874K942610KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)LFM1994-10-20
3126091924001264K934273KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)DMT1994-03-21
3126091077310998K924488KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)JIH1993-01-26
3126091789082088K922072KODAK EKTACHEM 250 ANALYERJJE1992-07-10
3126091678798591K910143KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)JIY1991-02-04
3126091949666447K903189KODATROL LIQUID CONTROL LEVELS I & IIDIF1990-08-22
3126091638493628K902356KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)DKJ1990-07-16
3126091214230933K861367KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)KLS1986-05-29
3126091524183834K840606EKTACHEM CLINICAL CHEM. SLIDESCIG1984-04-04
3126092068406495K820723KODAK EKTACHEM CLINICAL CHEM. NH3JID1982-04-01
3126091281180688K812027KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)CIW1981-08-03
3126091371050299K801649KODAK EKTACHEM CLINICAL CHEMISTRY SLIDESKNK1980-08-20
3126091861676557K791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONKSG1979-10-11
3126091428615879K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA2024-05-08
3126091069340945K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG2023-08-09
3126091791884017K231517VITROS Immunodiagnostic Products CEA Reagent PackDHX2023-08-23
3126091282088727K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK2022-12-12
3126091785280034K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW2023-09-05
3126091294492458K212648VITROS Immunodiagnostic Products CK-MB Reagent PackJHX2022-01-28
3126091695967673K210858VITROS Chemistry Products PHBR SlidesDLZ2021-08-13
3126091133252456K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC2021-10-04
3126091509633778K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsPMT2020-02-25
3126091226337325K191316VITROS XT Chemistry Products ALB-TP SlidesCIX2019-06-07
3126091740227709K190807VITROS XT Chemistry Products TBIL-ALKP SlidesCIG2019-04-26
3126091832500402K190520VITROS XT Chemistry Products GLU-Ca SlidesCGA2019-04-03
3126091946970502K190490VITROS XT Chemistry Products TRIG-CHOL SlidesCHH2019-03-27
3126091197415690K190326VITROS XT Chemistry Products UREA-CREA SlidesCDN2019-03-14
3126091815129592K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemJFY2018-10-30
3126091317000412K160712VITROS Chemistry Products hsCRP ReagentDCK2017-07-14
3126091509093750K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and IIPDJ2015-06-04
3126091801182073K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESCDT2013-05-31
3126091054257610K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIILPS2013-05-15
3126091279267715K121608VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORSMRG2013-02-15
3126091352147947K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESLBS2012-09-07
3126091650595488K101921VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITCEW2010-10-22
3126091799775839K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMJLW2008-12-22
3126092011202475K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMJLW2008-10-23
3126091846625306K081411VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2JGS2008-06-30
3126091833120988K073157VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2CEM2007-12-07
3126091036154314K072440VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)CJY2007-09-20
3126091996030432K063720VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERSDHA2007-04-09
3126091329574504K063164VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IVLDJ2006-12-28
3126091452233425K062838VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303MMI2006-12-19
3126091381141527K062637VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & VDJR2006-11-22
3126091836079730K062460VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND IIIDJG2006-12-15
3126091624343505K062285VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVJXM2006-12-22
3126091521610139K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSDIS2007-01-05
3126091547196623K062123VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IVDIO2006-11-16
3126092071253668K062094VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & VLCM2006-11-22
3126091377598937K062077VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSDKZ2006-11-22
3126091379663994K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668JMO2006-06-15
3126091591700812K060770VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLSLOL2006-09-15
3126091980739229K060678VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLSLOL2006-09-14
3126091457881243K060632VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158NBC2006-06-06
3126091772348712K060480VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLSCGR2006-07-03
3126091118348934K052889VITROS CA 19-9NIG2005-12-20
3126091543544029K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTJMO2005-12-23
3126091443702967K052819VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND IIIDEM2005-12-23
3126091790813102K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;GTQ2005-12-14
3126091748929405K043386VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND IIILEH2005-02-07
3126091492619590K043384VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND IIILDO2005-02-07
3126091990224715K042838VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & IIJIT2004-12-09
3126091425959969K042643VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND IIDCF2004-11-18
3126092007765821K042521VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERSJIT2004-11-18
3126091362672868K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIKLS2004-11-30
3126091876970905K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIICZW2004-10-19
3126091313910226K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHELCD2005-01-06
3126091874194284K042477VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEINDDG2004-11-19
3126091420712059K042476VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOSLEG2004-12-01
3126091930557530K042475VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCCFN2004-11-10
3126091079970070K042303VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLSJJX2004-09-27
3126091981076953K042006VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACELBS2004-10-28
3126091685499316K041863VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FSDHR2004-09-20
3126091138517118K041799VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FSNQD2004-08-25
3126091266150508K041720VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND IIMRR2004-08-25
3126091722759354K033300VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSDDR2003-11-05
3126091523796309K033127VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLSJJX2003-10-31
3126091379237638K032993VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLSJJX2003-10-31
3126091481584972K032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSJIS2003-08-13
3126091340028402K031924VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1JIT2003-08-07
3126091572343919K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSMJX2003-01-17
3126091711294983K023876VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1JIX2002-12-10
3126091980471652K012561VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLSJJX2001-08-29
3126091114285563K001266VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PACGN2000-05-02
3126091831636938K000566MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORSLTJ2000-03-09
3126091502742895DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total CalibratorsQVP2023-05-05
3126091032100462DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG CalibratorQVP2023-05-05
3126091147309209BP160122
3126091447646257BP050051
3126091468675505BK930030
3126091405723130BK920013
3126091770312845BK890021
3126091250312550BK820003
3126091365394054BK261331
3126091804860260BK251238
3126091291297273BK251237
3126091999795291BK220724
3126091309877319BK130032
3126091053414764
3126091076591108

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOM62011-07-20
JJX52004-09-27
JIT32004-12-09
JJY31998-11-04
DHA22024-05-08
CEW22023-09-05
NIG22023-08-09
QVP22023-05-05
NBC22021-10-04
CIG22019-04-26
DCK22017-07-14
LBS22012-09-07
JLW22008-12-22
LOL22006-09-15
JMO22006-06-15
KLS22004-11-30
JIS22003-08-13
DHX12023-08-23
LTK12022-12-12
JHX12022-01-28
DLZ12021-08-13
PMT12020-02-25
CIX12019-06-07
CGA12019-04-03
CHH12019-03-27
CDN12019-03-14
JFY12018-10-30
PDJ12015-06-04
CDT12013-05-31
LPS12013-05-15
MRG12013-02-15
JGS12008-06-30
CEM12007-12-07
CJY12007-09-20
DIS12007-01-05
LDJ12006-12-28
JXM12006-12-22
MMI12006-12-19
DJG12006-12-15
DJR12006-11-22