FDA.reportPublic FDA data

ABBOTT GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028091443002809144ABBOTT GmbH1N2027-01-01Max-Planck-Ring 2 Wiesbaden Hesse DE 65205

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
00380740150662Alinity - Alinity c Complement C3 Reagent Kit 300 Tests+1(877)422-2688xx@xx.xx
00380740150679Alinity - Alinity c Complement C4 Reagent Kit 300 Tests+1(877)422-2688xx@xx.xx
00380740150693Alinity - Alinity c Immunoglobulin M Reagent Kit 360 Tests+1(877)422-2688xx@xx.xx
00380740153922Alinity - Alinity c Immunoglobulin G Reagent Kit 360 Tests+1(877)422-2688xx@xx.xx
00380740186173Alinity - Alinity c GluC2 Assay File+1(877)422-2688xx@xx.xx
00380740186180Alinity - Alinity c GluC2-U Assay File+1(877)422-2688xx@xx.xx
00380740186197Alinity - Alinity c GluC2-CSF Assay File+1(877)422-2688xx@xx.xx
00380740199265Alinity - Anti-HCV Next Calibrator+1(877)422-2688xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1155391185492289P980007AXSYM FREE PSAMTG2004-02-05
1155391256468909P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSAMTF1991-09-25
1155391513741180P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitLOM2022-08-10
1155391316120706P120008ABBOTT ARCHITECT AFP ASSAYLOK2012-11-28
1155391238379979P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLSLOM2012-04-12
1155391571913282P080023ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLSSEI2009-04-10
1155391203759096P060035ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSSEI2007-11-06
1155391697919650P050051ABBOTT ARCHITECT AUSABSEI2006-06-01
1155391457975421P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLMZO2006-06-07
1155391059413930K990774ABBOTT ARCHITECT CEADHX1999-05-11
1155391757070345K983759ABBOTT ARCHITECT FERRITINDBF1998-12-07
1155391128228408K983442ABBOTT ARCHITECT TSHJLW1998-11-20
1155391632719028K983441C3CZW1998-11-04
1155391596630445K983440ABBOTT ARCHITECT TOTAL T4KLI1998-11-25
1155391138439833K983439ABBOTT ARCHITECT FREE T3CDP1998-11-20
1155391066930130K983434ABBOTT ARCHITECT TOTAL T3CDP1998-11-20
1155391446967412K983424ABBOTT ARCHEITECT TOTAL B-HCGDHA1998-12-01
1155391971712753K983359IGACZP1998-11-04
1155391491571274K983356C4DBI1998-11-04
1155392049809977K983289APOLIPOPROTEIN A1DER1999-01-29
1155391571696246K983281APOBDFC1999-01-26
1155391263096791K983221IGGDEW1998-11-04
1155391361119208K983167TRFDDG1998-11-04
1155391277809958K983132IGMDFT1998-11-04
1155391819648818K262156Anti-HCV NextMZO2026-09-23
1155391268545185K252424Anti-HCV NextMZO2026-04-28
1155391402866553K252357Glucose2CFR2025-10-24
1155391309798336K243500ARCHITECT iGentamicinLCD2025-07-09
1155391502685312K243168Alinity i Rubella IgGLFX2025-06-20
1155391926482337K242585Cystatin CNDY2025-05-16
1155391116478964K233932Alinity i Toxo IgMLGD2024-08-30
1155391550578796K233541ARCHITECT Active-B12 (Holotranscobalamin)CDD2024-07-31
1155391378319410K232669TBIQAT2023-09-29
1155391479988809K230994Alinity i STAT High Sensitivity Troponin-IMMI2023-05-04
1155391347155115K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA2023-06-05
1155391124229904K223602Traumatic brain injury (TBI) testQAT2023-03-02
1155391409163087K223324Total Bilirubin2CIG2022-12-29
1155391102197463K223317Alkaline Phosphatase2CJE2023-07-21
1155391823985665K222850HAVAb IgG IILOL2023-08-10
1155391574018327K220949Architect CMV IgGLFZ2022-10-27
1155392019731591K213486GLP systems TrackJGS2022-03-10
1155391942038913K210633Amylase2JFJ2022-05-26
1155391150106102K210596ARCHITECT Toxo IgGLGD2022-05-19
1155391646036763K210452Creatinine2CGX2022-03-22
1155392020778306K203597Cholesterol2CHH2022-06-30
1155391786443780K203530Albumin BCP2CJW2022-03-18
1155391534300189K203248Albumin BCG2CIX2021-11-23
1155391085569000K202525Alinity i STAT High Sensitivity Troponin-IMMI2022-05-19
1155391565864493K192118CRP VarioDCK2019-11-08
1155391112874795K191595ARCHITECT STAT High Sensitivity Troponin-IMMI2019-09-13
1155391634694401K190294CELL-DYN Emerald 22 AL SystemGKZ2019-03-15
1155391372859818K181748MagnesiumJGJ2018-09-12
1155391734401447K173833CRP VarioNQD2018-09-27
1155391856662227K173122Abbott Architect Free T4CEC2017-10-27
1155392033101201K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsPRI2017-06-01
1155392037553514K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA2017-10-23
1155391738223887K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMCFR2017-10-19
1155391439835765K170160Abbott ARCHITECT Free T3JIT2017-02-15
1155391440313273K162530Multichem IA PlusJJY2017-03-31
1155391147876366K162514Multichem A1cJJX2016-10-26
1155391396157287K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP ControlLIP2016-06-15
1155391307909812K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsMRG2016-08-12
1155391840620959K151566Abbott ARCHITECT Total T4 CalibratorsJIT2015-07-10
1155391457141733K151502ARCHITECT ROMAONX2016-04-28
1155391250633905K140654Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsPDJ2015-05-22
1155391123359997K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLSOSX2014-12-23
1155391453839675K132751MULTICHEM S PLUS / S PLUS (ASSAYED)JJY2013-10-22
1155391884072065K132400LP(A) CALIBRATORS, AND LP(A) CONTROLSJIT2013-12-19
1155391108188260K132174MULTICHEM WBTDIF2013-09-20
1155391720782833K132091MULTICHEM IA AND IA PLUSJJY2013-09-20
1155392072038942K131993MULTICHEM UJJY2013-10-15
1155391129080842K131992MULTICHEM PJJY2013-09-25
1155391233208789K130255HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLSPDJ2014-02-28
1155392062421044K123379ABBOTT ARCHITECT FREE T4CEC2012-11-27
1155391268567983K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORJIX2013-01-14
1155391206688777K121842ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CLCP2012-12-12
1155391010283374K121314ARCHITECT B12CDD2012-05-17
1155391802801628K120009TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)CDZ2012-09-11
1155391953591943K113704ARCHITECT HAVAB-GLOL2012-06-28
1155391046037707K112443ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)CDD2011-12-19
1155392003015212K111023ABBOTT ARCHITECT LH CALIBRATORSJIT2011-06-10
1155391554867565K110381CELL-DYN EMERALD 22 SYSTEMGKZ2011-12-22
1155391242851138K103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSKLT2011-10-14
1155391909252484K102699ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSLCD2011-04-01
1155391917963340K093957ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,OIU2010-03-18
1155391655484019K092740ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74CGN2010-03-05
1155391800549526K090358ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35LEG2009-08-06
1155392063792072K083868ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35NHX2009-09-25
1155391048643224K082953ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01KXT2008-12-22
1155391077680500K082141ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10JIT2008-09-03
1155391122217899K081495CELL-DYN EMERALD SYSTEMGKZ2009-02-04
1155391581917541K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33DLZ2008-09-26
1155391368252630K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01DIP2008-09-11
1155391313725348K073640ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSLPS2008-04-24
1155391142401116K073634MULTIGENT CREATININE (ENZYMATIC) ASSAYJFY2008-06-19
1155391871033942K072036ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01LEH2008-03-19
1155391012845311K070987SENTINEL LITHIUM ASSAYNDW2007-08-02
1155391208625573K070971MODIFICATION TO SENTINEL CLIN CHEM CALJIX2007-05-23
1155392008481014K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)LGS2007-06-08
1155392063676285K063329ABBOTT ARCHITECT HAVAB-MLOL2007-04-16
1155391845986861K063232ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01CEW2007-06-19
1155391880260981K062204ARCHITECT CORTISOL ASSAYJFT2006-09-22
1155391615276561K060964ARCHITECT BNP ASSAY, MODEL 8K28NBC2006-05-25
1155391049324330K060818ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01CDZ2007-01-23
1155391475996772K060359ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10JIT2006-04-14
1155391495491381K060027ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)JJX2006-01-26
1155391437123803K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSJZO2006-07-18
1155391431936302K052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMJZO2006-05-10
1155391133261303K052000ARCHITECT CA 19-9XR ASSAYNIG2005-10-25
1155391057207900K051457SENTINEL PLASMAPROTEINS CAL 3XJIX2005-07-25
1155391116243688K051456SENTINEL CERULOPLASMINJFR2005-10-21
1155391568496672K051115SENTINEL IRON LIQUIDJIY2005-08-25
1155391219930796K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYJIF2005-11-25
1155391127363436K051111SENTINEL UIBC LIQUIDJQF2005-11-17
1155391188053802K050836CRP DIAGNOSTIC ASSAYDCK2005-08-08
1155391803607864K042924ARCHITECT STAT MYO IMMUNOASSAYDDR2005-01-24
1155391236205673K042732ARCHITECT CA 15-3 ASSAYMOI2004-12-22
1155391549842311K042731ARCHITECT CA 125 II ASSAYLTK2004-11-19
1155391665855756K041687ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATORJJX2004-08-18
1155391124779476K041596ARCHITECT STAT CK-MB IMMUNOASSAYJHX2004-07-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIT72017-02-15
JJY52017-03-31
LOM42012-04-12
MZO32026-09-23
CDD32024-07-31
LOL32023-08-10
DHA32023-06-05
MMI32023-05-04
GKZ32019-03-15
JJX32016-10-26
JIX32013-01-14
CFR22025-10-24
LCD22025-07-09
LGD22024-08-30
QAT22023-09-29
DCK22019-11-08
CEC22017-10-27
PDJ22015-05-22
CDZ22012-09-11
JZO22006-07-18
CDP21998-11-20
LFX12025-06-20
NDY12025-05-16
CJE12023-07-21
CIG12022-12-29
LFZ12022-10-27
LOM 12022-08-10
CHH12022-06-30
JFJ12022-05-26
CGX12022-03-22
CJW12022-03-18
JGS12022-03-10
CIX12021-11-23
NQD12018-09-27
JGJ12018-09-12
PRI12017-06-01
MRG12016-08-12
LIP12016-06-15
ONX12016-04-28
OSX12014-12-23

GUDID#

200 records. Showing 1-40. Next