FDA.reportPublic FDA data

Siemens Healthcare Diagnostics Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12199131219913Siemens Healthcare Diagnostics Inc.1N2026-01-01333 Coney Street E Walpole MA US 02032
24322352432235Siemens Healthcare Diagnostics Inc.1Y2026-01-01511 Benedict Ave Tarrytown NY US 10591
25175062517506SIEMENS HEALTHCARE DIAGNOSTICS INC.1N2026-01-01500 GBC DR, PO Box 6101 NEWARK DE US 19714
30074948753007494875Siemens Healthcare Diagnostics Inc.1Y2026-01-012150 Stanley Road Suite 151 Plainfield IN US 46168
22471171000122204Siemens Healthcare Diagnostics Inc.1N2020-04-2562 FLANDERS-BARTLEY RD. FLANDERS NJ US 07836
30039329693003932969SIEMENS HEALTHCARE DIAGNOSTICS INC.1N2020-04-25725 Potter St Berkeley CA US 94710

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00630414596167Atellica CH ASO_2 - Antistreptolysine O (ASO_2) Atellica CH - RGT 1200T+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM
00630414596174Atellica CH hsCRP - High Sensitivity C-Reactive Protein (hsCRP) Atellica CH - RGT 740T+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM
00630414596198Atellica CH CRP_2 - C-Reactive Protein_2 (CRP_2) Atellica CH - RGT 1000T+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM
00630414596259Atellica CH PreAlb - Prealbumin (PreAlb) Atellica CH - RGT 400T+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM
00630414596440Atellica CH GGT - G-Glutamyltransferase (GGT) Atellica CH - RGT 1792T+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM
00630414597508Atellica CH hsCRP Calibrator - High Sensitivity C-Reative Protein (hsCRP) Calibrator Atellica CH - CAS 5 x 1 x 1.0mL+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM
00630414597515Atellica CH CRP_2 Calibrator - C-Reative Protein (CRP) Calibrator Atellica CH - CAL 5 x 1 x 1.0mL+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM
00630414611075Atellica CH Crea3 - Atellica CH Creatinine (Crea3) Reagent+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
256961201402419P990055BAYER IMMUNO 1 COMPLEXED PSA ASSAYNAF2000-09-08
676631201402419P990055BAYER IMMUNO 1 COMPLEXED PSA ASSAYNAF2000-09-08
676631754968213P950021ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYMTG1995-12-22
256961754968213P950021ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYMTG1995-12-22
676631370853759P930036ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSLOK1995-09-29
256961370853759P930036ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSLOK1995-09-29
735021211087562P920031EMIT 2000 CYCLOSPORINE SPECIFIC ASSAYMKW1996-10-02
676631481365233P250026Atellica IM free PSA II (fPSAII)MTG2026-05-11
256961481365233P250026Atellica IM free PSA II (fPSAII)MTG2026-05-11
256961816221269P240021Atellica IM Total PSA II (tPSAII)MTF2025-12-03
676631816221269P240021Atellica IM Total PSA II (tPSAII)MTF2025-12-03
256961748108776P210019ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)SEI2022-07-27
676631437315834P200017ADVIA Centaur Anti-HBe2 (aHBe2) assaySEI2021-07-14
676631018236792P160016VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)OBF2017-03-14
676631014775342P110041ADVIA CENTAUR HBSAGIILOM2014-05-16
256961014775342P110041ADVIA CENTAUR HBSAGIILOM2014-05-16
256961731031110P100039ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIALSEI2012-01-20
676631731031110P100039ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIALSEI2012-01-20
676631184122186P090024ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIALLOM2011-10-11
256961184122186P090024ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIALLOM2011-10-11
676631784186430P060005IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYSMTG2007-05-11
256962037006788P040018ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALSLOL2004-12-22
676632037006788P040018ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALSLOL2004-12-22
676631957640001P040017ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALSLOL2005-03-07
256961957640001P040017ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALSLOL2005-03-07
256961242244527P040004ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALSSEI2004-12-22
676631242244527P040004ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALSSEI2004-12-22
676631544372128P030056ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSMZO2004-12-22
256961544372128P030056ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSMZO2004-12-22
676631075086351P030049ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIALLOM2005-05-26
256961075086351P030049ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIALLOM2005-05-26
676631246570470P030040ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSEI2004-08-06
256961246570470P030040ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSEI2004-08-06
735021107299342P020027DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSMTG2003-01-24
256991237001991P010053IMMULITE 2000 XPI ANTI-HBC IMGSEI2002-07-26
676631237001991P010053IMMULITE 2000 XPI ANTI-HBC IMGSEI2002-07-26
676631301824155P010052IMMULITE 2000 XPI ANTI-HBSSEI2002-07-22
676631190112282P010051IMMULITE 2000 XPI ANTI-HBCSEI2002-07-24
676631769657209P010050IMMULITE 2000 XPI HBSAGLOM2002-07-26
676631260715183P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPLOK2001-11-09
676631504223654P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPLOK2001-11-09
735021617216246P000021DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGELTJ2001-07-05
735021936598310K994296DIMENSION C3 FLEX REAGENT CARTRIDGECZW2000-03-01
735021274792860K994294DIMENSION TRNF FLEX REAGENT CARTRIDGEDDG2000-02-04
735021775561343K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDBI2000-03-01
735021687411995K994291DIMENSION SPECIAL PROTEIN CALIBRATORJIT2000-03-01
735021050899674K994115TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGEJMO2000-01-28
735021435585047K994114DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATORJIS2000-01-20
735021338541334K994005SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129ULDJR2000-01-20
676631338541334K994005SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129ULDJR2000-01-20
735021999141229K993987SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129ULKLT2000-01-27
676631999141229K993987SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129ULKLT2000-01-27
735021324846678K993986SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129ULKXS2000-01-27
735021472836099K993985SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129ULJXM2000-01-27
676631472836099K993985SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129ULJXM2000-01-27
735021783635667K993984SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129ULLDJ2000-01-18
676631783635667K993984SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129ULLDJ2000-01-18
735021431457091K993983SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029ULLCM2000-01-27
676631431457091K993983SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029ULLCM2000-01-27
735021601577916K993981SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129ULJXN2000-02-01
676631601577916K993981SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129ULJXN2000-02-01
735021872988864K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULDML2000-02-01
676631872988864K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULDML2000-02-01
676631077092285K993952IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6LFZ1999-12-16
676631365039702K993825PARA TECH PLUS RETICSJCN1999-11-30
735021645661123K993755EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5DKB1999-12-21
256961729953367K993571BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12CDD1999-12-16
676631729953367K993571BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12CDD1999-12-16
676631929151528K993309BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAYMMI1999-12-06
256961929151528K993309BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAYMMI1999-12-06
676631915743077K993254IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06CGN1999-11-12
256961915743077K993254IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06CGN1999-11-12
676631821644899K993251IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6LIG1999-11-17
676631755738419K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMMSJ2000-02-15
676631606389417K992257NEW MULTIPLES REAGENT STRIPSJIR1999-11-24
256961034564098K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYDBF1999-08-05
676631034564098K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYDBF1999-08-05
676631890352808K991795IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5MMI1999-06-09
256961143228373K991692CHIRON DIAGNOSTICS ACS: 180 FT3CDP1999-06-18
676631143228373K991692CHIRON DIAGNOSTICS ACS: 180 FT3CDP1999-06-18
676631800521964K991576ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMCIX1999-06-30
676631109109041K991315MICROALBUSTIX REAGENT STRIPS (OTC)JIR1999-11-12
676631912371222K991096IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06JZO1999-05-13
676631301795683K991094IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6JZO1999-05-13
735021979598595K991080ACCUSIGN MTD, BIOSIGN MTDDJR1999-04-15
735021777991238K991079ACCUSIGN BZO, BIOSIGN BZO, STATUS BZOJXM1999-04-15
735021657720936K991018ACCUSIGN BAR, BIOSIGN BAR, STATUS BARDIS1999-04-15
735022040000595K990824REVISED C-REACTIVE PROTEIN CALIBRATORJIT1999-04-16
735021894984709K990786ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/LAG1999-03-26
735021842909810K990553IGM FLEX REAGENT CARTRIDGECFQ1999-03-22
735021558694440K990552IMMUNOGLOBULIN A TEST SYSTEMCFQ1999-03-25
735022046595281K990551IGG FLEX REAGENT CARTRIDGECFQ1999-03-25
676631143199010K990346BAYER ADVIA 1650 CHEMISTRY SYSTEMJGS1999-05-21
735021726328667K990251DGTX FLEX REAGENT CARTRIDGE, MODEL DF36LFM1999-03-31
676631867383191K990222IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6DHA1999-02-26
676631129190583K984501DADE BEHRING BFTIIJPA1999-07-28
735021233316557K984193DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATORJIT1998-12-14
735022009634635K984191MYOGLOBIN FLEX REAGENT CARTRIDGEDDR1998-12-10
735021365740856K984067STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAKJHX1999-01-13
256991365740856K984067STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAKJHX1999-01-13
735021798109729K984065STRATUS (R) CS MYOGLOBIN (MYO) TESTPAKDDR1998-12-14
735021649950326K983850DIMENSION AHDL CALIBRATORJIT1998-11-18
735021045775812K983548FERRITIN CALIBRATORJIT1998-10-27
676631270509958K983391IMMULITE 2000 OM-MA MODEL L2KOP2LTK1998-10-15
676631462865555K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1GGT1999-07-12
676631854629953K983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSDKB1998-11-05
735021686681497K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PDKE1998-09-28
735021665949641K982880DIMENSION(R) VALPROIC (VALP) ACID METHODLEG1998-08-25
676631665949641K982880DIMENSION(R) VALPROIC (VALP) ACID METHODLEG1998-08-25
676631214412524K982802BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)GKZ1998-09-22
676631825205341K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYMOI1998-10-15
256961825205341K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYMOI1998-10-15
676631255196624K982529RANDOX DIRECT LDL CHOLESTEROLMRR1998-09-11
676631371556262K982466IMMULITE THYROGLOBULIN MODEL LKTYMSW1999-03-12
676631558824849K982341DIRECT HDL-CHOLESTROL LIQUIDLBS1998-07-30
735021582505197K982292PREALBUMIN CALIBRATORJIT1998-08-13
735021821771763K981801ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCALFH1998-08-25
256961293176842K981478ACS:CENTAUR CEADHX1998-08-12
676631293176842K981478ACS:CENTAUR CEADHX1998-08-12
676631299889433K981297IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5LTK1998-09-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX392015-07-17
JIT372016-11-17
JIX242015-12-18
JLW222026-02-06
MMI182024-07-25
LOM172014-05-16
NBC152023-09-24
LCP142014-01-24
DKB142009-06-01
CDZ132019-08-28
CDD132017-10-27
JZO112025-10-17
DJG112023-07-25
CHL112020-03-27
JJE112013-03-22
CIG102026-02-27
GKZ102024-05-21
MOI102024-03-13
LEH102023-08-08
KXT102021-07-16
DIO102017-10-25
CEW102017-05-23
DHB102014-05-28
DKZ102006-05-19
KLT102002-01-15
DIS102001-04-20
DHA92021-07-13
DLJ92008-08-22
KLS92004-10-28
JGS82023-07-25
LOL82016-10-13
CEC82014-11-26
MKW82008-09-11
LCD82001-09-18
JXM82001-05-16
LDP72026-07-24
NQD72024-01-18
DHX72020-04-13
LTK72020-04-06
JIS72012-08-14

PMA#

71 records. Showing 1-40. Next

PMN#

79 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next