FDA.reportPublic FDA data

Mary Seeger

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96108063001644026Mary Seeger1N2026-01-01Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown NY US 10591
30028069443002806944Mary Seeger1N2026-01-01Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown NY US 10591

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
257001257367261P930027IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTSMTF1995-09-15
257001748108776P210019ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)SEI2022-07-27
257001784186430P060005IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYSMTG2007-05-11
257001237001991P010053IMMULITE 2000 XPI ANTI-HBC IMGSEI2002-07-26
257001301824155P010052IMMULITE 2000 XPI ANTI-HBSSEI2002-07-22
257001190112282P010051IMMULITE 2000 XPI ANTI-HBCSEI2002-07-24
257001769657209P010050IMMULITE 2000 XPI HBSAGLOM2002-07-26
257001807787145P010050IMMULITE 2000 XPI HBSAGLOM2002-07-26
257001260715183P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPLOK2001-11-09
257001504223654P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPLOK2001-11-09
257001428856930K994085IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5DHA2000-01-28
257001077092285K993952IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6LFZ1999-12-16
734851850055386K993332GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05GGC2000-02-16
734851535052051K993310APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPHJJY1999-11-30
734851606558386K993273N LATEX FERRITINDBF1999-11-23
257001915743077K993254IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06CGN1999-11-12
257001821644899K993251IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6LIG1999-11-17
734851179116410K992957ADVANCED D-DIMERDAP2000-01-28
734851179332294K992456GRADILEIDEN V TESTGGW1999-12-21
257002027486651K992105IMMULITE TURBO INTACT PTH, MODEL LSKPTZCEW1999-07-06
257001492379427K991796IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5DDR1999-06-09
257001890352808K991795IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5MMI1999-06-09
734851323270752K991787N LATEX IGE MONO REAGENTDGC1999-07-07
257001189708603K991277MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5DDR1999-04-27
734851803436470K991157N LATEX STFR REAGENTDDG1999-08-02
257001912371222K991096IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06JZO1999-05-13
257001301795683K991094IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6JZO1999-05-13
257001867383191K990222IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6DHA1999-02-26
734851129190583K984501DADE BEHRING BFTIIJPA1999-07-28
257001486726932K983972IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15MMI1998-12-07
257001270509958K983391IMMULITE 2000 OM-MA MODEL L2KOP2LTK1998-10-15
257001462865555K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1GGT1999-07-12
257001381278330K982468IMMULITE 2000 THYROGLOBULIN MODEL L2KTYMSW1999-03-12
257001371556262K982466IMMULITE THYROGLOBULIN MODEL LKTYMSW1999-03-12
257001590244165K982078IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)LFX1998-12-11
257001299889433K981297IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5LTK1998-09-18
257001276813456K980855IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KITDHX1998-04-21
257001187013732K980833IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5JMM1998-05-01
257001046641601K980206IMMULITE ANTI-TG ABJZO1998-05-01
257001234175302K974634IMMULITE FREE T3CDP1998-01-02
734851500578931K974343DADE INNOVINGJS1998-07-22
734851789546947K972929N ANTISERUM TO HUMAN ALBUMINDCF1997-10-20
734851836622221K972116VON WILLEBRAND REAGENTGGP1997-07-25
257001126318699K971312IMMULITE PYRILINKS-DJMM1997-05-27
257001615689747K971177IMMULITE VITAMIN B12 (LKVB1,LKVB5)CDD1997-05-16
257001527878349K971051IMMULITE THYROID AUTOANTIBODY CONTROL MODULEJJX1997-04-10
257001921070330K970877IMMULITE CEADHX1997-09-22
734851769305582K970645BC THROMBIN REAGENTGJA1997-05-19
734851177540388K970431BEHRING COAGULATION SYSTEMJPA1997-05-05
257001331779534K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERJJE1997-04-08
734851223656799K964527N RHEUMATOLOGY STANDARD SLJIX1997-01-15
257001967026181K963695IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZJZO1997-01-17
257001724927349K963613IMMULITE RUBELLA IGGLFX1997-04-02
257001837131250K963240IMMULITE ACTH CONTROL MODULE (LACCM)JJX1996-08-29
257001010693945K962936IMMULITE TOXOPLASMA QUANTITATIVE IGGLGD1997-04-24
734851188654202K962410N PROTEIN STANDARD PYJIX1996-07-16
734851307393798K962407N/T PROTEIN CONTROL PYGIL1996-07-29
734851952626875K960257N ANTISERUM TO C1 INHIBITORDBA1996-08-01
257001579065770K960067IMMILITE TOTAL IGEJHR1996-02-14
257001507889303K960066IMMULITE ACTHCKG1996-02-16
734851791066185K955450PATHROMTIN SLGFO1996-04-19
257001689736487K955440IMMULITE SHBG (MODIFICATION)CDZ1995-12-21
257001591585426K955376IMMULITE HGHCFL1996-02-16
257001579358443K954569IMMULITE THEOPHYLLINEKLS1995-11-13
257001427405407K950672IMMULITE CMV IGGLFZ1996-06-17
257001133911549K950670IMMULITE HERPES I AND II IGGLGC1996-06-21
257002011076802K950072IMMULITE(R) TBGJJX1995-04-03
257001134448353K944211IMMULITE PROGESTERONEJLS1994-12-19
734851260073523K943997BEHRING NEPHELOMETER IIDEW1994-10-03
257001195058038K943767IMMULITE C-PEPTIDEJKD1995-03-23
257001532636877K943235IMMULITE DIGITOXINLFM1994-10-27
257001162813475K941564IMMULITE ALATOP ALLERGY SCREENDHB1994-12-19
257001546625014K940006IMMULITE THIRD GENERATION (MODIFICATION)JLW1994-12-19
257001204055853K935806IMMULITE DHEA-S04JKC1994-04-26
734851667034498K934326MULTIFIBREN UKQJ1994-04-19
257001785197075K933212IMMULITE RAPID TSHJLW1994-12-19
734851245008750K933125BERICHROM ANTITHROMBIN III (A)JPE1994-04-19
257001356169105K932926IMMULITE ESTRADIOLCHP1994-01-10
734851428398496K932787BATROXOBIN REAGENTJCO1993-11-29
257001337177686K931704IMMULITE FREE T4CEC1993-08-16
257001116540472K931703IMMULITE TOTAL IGEJHR1993-08-16
257001667944059K931702IMMULITE BETA-2-MICROGLOBULINJZG1993-09-24
257001948940889K931701IMMULITE PAPJFH1994-01-27
257001284587818K931409IMMULITE CORTISOLCGR1993-05-11
734852022902480K930157TEST THROMBINGJA1993-05-14
257001009900509K930007IMMULITE TSH THIRD GENERATION CONTROLJJX1993-08-16
734851689251542K925988MULTIFIBRENKQJ1993-03-01
257001483274907K925848IMMULITE FERRITINJMG1993-01-13
257001695253988K925846IMMULITE PROLACTINCFT1993-03-05
734852050118199K925452DADE HEPZYMEJBR1993-01-11
734851861573914K925200BERICHROM HEPARINKFF1993-06-28
734851827278117K924509CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTIONJPA1992-12-21
734851758264855K924400CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMAGJT1993-06-08
734851643928707K924396CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMAGJT1993-05-21
734851004013463K924394CLOTTING FACTOR V DEFICIENT PLASMAGJT1992-12-01
734851386562761K924124BEHRING FIBRINTIMER AJPA1992-12-01
734851923745944K922326LUPO-TEST REGEANTGIR1993-04-06
734851625634301K922156LUCOR CONFIRMATORY REAGENTGIR1993-04-06
257001890172098K921704IMMULITE(R) FSHCGJ1992-06-09
257001042378600K920411IMMULITE HLHCEP1992-03-11
257001848044900K911796IMMULITE(TM) HCGDHA1991-06-20
257001912862237K910677IMMULITE(TM) T-UPTAKECEE1991-04-29
257001825780463K910261IMMULITE(TM) TOTAL T4KLI1991-04-16
257001145615577K905215IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZERJJQ1991-01-11
734851145615577K905215IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZERJJQ1991-01-11
257002040290895K905214IMMULITE (TM) TOTAL T3CDP1991-02-01
734851291644764K904254NA ALPHA 1 MICROGLOBULIN KITJZG1991-04-05
734851981821447K903853RAPITEX (R) CRP NEWDCN1990-08-30
734851325892134K903852RAPITEX(R) RF NEWDHR1990-08-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX312015-04-13
DHB162014-05-28
JPA92009-01-26
CFN82023-12-13
GGP82023-06-02
JZO62025-10-17
DFH62022-03-02
JIX62007-10-17
CEW62006-02-03
JZG52009-03-13
LOM52002-07-26
NQD42024-01-18
DAP42010-11-29
DDG42008-08-08
KQJ42005-06-29
MSW32025-06-20
JBQ32025-03-28
DCN32023-11-27
LTK32023-09-08
CGR32021-01-15
KFF32017-08-22
NDY32017-05-12
JLW32016-05-31
LPS32006-12-28
GGN32004-12-01
CDZ32003-10-10
LFX32002-01-10
JFH32000-02-23
DHA32000-01-28
GGW31999-12-21
DDR31999-06-09
JMM31998-05-01
CDP31998-01-02
JHR31996-02-14
GJT31993-06-08
JJQ31991-01-11
JIT22011-04-07
CEC22009-02-02
DEB22008-07-21
DBA22007-12-21