FDA.reportPublic FDA data

Mary Seeger

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80208883007019572Mary Seeger1N2027-01-01Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown NY US 10591
30028069443002806944Mary Seeger1N2027-01-01Siemens 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
257001915743077K993254IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06CGN1999-11-12
257001821644899K993251IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6LIG1999-11-17
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
257001189708603K991277MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5DDR1999-04-27
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
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
676621284201540K971998ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMGKL1997-08-29
676621872207060K971998ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMGKL1997-08-29
257001126318699K971312IMMULITE PYRILINKS-DJMM1997-05-27
257001615689747K971177IMMULITE VITAMIN B12 (LKVB1,LKVB5)CDD1997-05-16
257001527878349K971051IMMULITE THYROID AUTOANTIBODY CONTROL MODULEJJX1997-04-10
257001921070330K970877IMMULITE CEADHX1997-09-22
257001331779534K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERJJE1997-04-08
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
257001579065770K960067IMMILITE TOTAL IGEJHR1996-02-14
257001507889303K960066IMMULITE ACTHCKG1996-02-16
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
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
257001785197075K933212IMMULITE RAPID TSHJLW1994-12-19
257001356169105K932926IMMULITE ESTRADIOLCHP1994-01-10
257001337177686K931704IMMULITE FREE T4CEC1993-08-16
257001116540472K931703IMMULITE TOTAL IGEJHR1993-08-16
257001667944059K931702IMMULITE BETA-2-MICROGLOBULINJZG1993-09-24
257001948940889K931701IMMULITE PAPJFH1994-01-27
257001284587818K931409IMMULITE CORTISOLCGR1993-05-11
257001009900509K930007IMMULITE TSH THIRD GENERATION CONTROLJJX1993-08-16
257001483274907K925848IMMULITE FERRITINJMG1993-01-13
257001695253988K925846IMMULITE PROLACTINCFT1993-03-05
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
257002040290895K905214IMMULITE (TM) TOTAL T3CDP1991-02-01
257001306836495K901859COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2JHR1990-05-03
257001439119878K883267IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)CDZ1988-10-31
257001467708472K854066DOUBLE ANTIBODY C-PEPTIDE RIA KITJKD1985-11-12
257001904689644K851338DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURIJIR1986-04-07
257001511271929K833489DPC GASTRIN KITCGC1984-01-30
257001176746804K810891COAT-A-COUNT CORTISOL RIA KITCGR1981-04-14
257001146836755K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)JNL2025-12-04
257001101659492K250250ADVIA Centaur Anti-Thyroid Peroxidase IIJZO2025-10-17
257001633857100K242981Atellica IM Thyroglobulin (Tg)MSW2025-06-20
257001964555676K233946IMMULITE® 2000 BR-MAMOI2024-03-13
676621154356452K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)JLW2023-07-13
257001606871661K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MALTK2023-09-08
257001012899438K202826IMMULITE® 2000 CortisolCGR2021-01-15
676621845685497K162977ADVIA 2120i, ADVIA 2120GKZ2017-08-11
676621543212023K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)JGS2017-03-09
257001586298934K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4JLW2016-05-31
257001425658564K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO2016-03-03
676621791253773K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemJLW2015-11-20
676621670338437K151767Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorJGS2015-12-11
257001688192423K150132IMMULITE IGF Control Module, IMMULITE Gastrin Control ModuleJJX2015-04-13
257001408392035K143639IMMULITE 2000 CEA Calibration Verification MaterialJJX2015-01-23
257002013140840K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification MaterialJJX2015-02-25
257001890823820K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification MaterialJJX2015-01-14
257001647893007K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification MaterialJJX2015-02-26
257001098172196K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification MaterialJJX2014-12-24
257001227098387K142878IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification MaterialJJX2014-10-30
257001169360090K142811IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)JJX2014-10-29
676621141034726K141999ADVIA CENTAUR TSHJLW2015-04-22
257001415882498K141772IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIALJJX2014-08-19
257001700294045K141444IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CALJJX2014-07-09
257001528548018K140818IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN CJJX2014-05-01
257001454430257K140541IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE CJJX2014-04-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX302015-04-13
DHB162014-05-28
JZO62025-10-17
JLW62023-07-13
CEW62006-02-03
LOM52002-07-26
GKZ42017-08-11
MSW32025-06-20
LTK32023-09-08
CGR32021-01-15
CDZ32003-10-10
LFX32002-01-10
JFH32000-02-23
DHA32000-01-28
JMM31998-05-01
CDP31998-01-02
JHR31996-02-14
MOI22024-03-13
JGS22017-03-09
CEC22009-02-02
CDD22004-07-02
JHX22002-07-22
LGD22002-01-10
LOK22001-11-09
LGC22001-04-18
LFZ21999-12-16
DDR21999-06-09
MMI21999-06-09
DHX21998-04-21
GKL21997-08-29
JKD21995-03-23
JLS21994-12-19
CHP21994-01-10
JZG21993-09-24
CFT21993-03-05
CGJ21992-06-09
CEP21992-03-11
CEE21991-04-29
JJQ21991-01-11
CGC21984-01-30