FDA.reportPublic FDA data

Sara Qadri

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30028091443002809144Sara Qadri1N2026-01-01675 N Field Dr Dept C2D8 Bldg CP01 Floor-3 Lake Forest IL US 60045
30050941233005094123Sara Qadri1N2026-01-01675 N Field Dr Dept C2D8 Bldg CP01 Floor-3 Lake Forest IL US 60045
30162447603016244760Sara Qadri1N2026-01-01675 N Field Dr Dept C2D8 Bldg CP01 Floor-3 Lake Forest IL US 60045
30232684353023268435Sara Qadri1N2026-01-01675 N Field Dr Dept C2D8 Bldg CP01 Floor-3 Lake Forest IL US 60045

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
1147081757070345K983759ABBOTT ARCHITECT FERRITINDBF1998-12-07
1155391757070345K983759ABBOTT ARCHITECT FERRITINDBF1998-12-07
1147081128228408K983442ABBOTT ARCHITECT TSHJLW1998-11-20
1155391128228408K983442ABBOTT ARCHITECT TSHJLW1998-11-20
1147081632719028K983441C3CZW1998-11-04
1155391632719028K983441C3CZW1998-11-04
1147081596630445K983440ABBOTT ARCHITECT TOTAL T4KLI1998-11-25
1155391596630445K983440ABBOTT ARCHITECT TOTAL T4KLI1998-11-25
1147081138439833K983439ABBOTT ARCHITECT FREE T3CDP1998-11-20
1155391138439833K983439ABBOTT ARCHITECT FREE T3CDP1998-11-20
1147081066930130K983434ABBOTT ARCHITECT TOTAL T3CDP1998-11-20
1155391066930130K983434ABBOTT ARCHITECT TOTAL T3CDP1998-11-20
1147081446967412K983424ABBOTT ARCHEITECT TOTAL B-HCGDHA1998-12-01
1155391446967412K983424ABBOTT ARCHEITECT TOTAL B-HCGDHA1998-12-01
1147081971712753K983359IGACZP1998-11-04
1155391971712753K983359IGACZP1998-11-04
1147081491571274K983356C4DBI1998-11-04
1155391491571274K983356C4DBI1998-11-04
1147082049809977K983289APOLIPOPROTEIN A1DER1999-01-29
1155392049809977K983289APOLIPOPROTEIN A1DER1999-01-29
1147081571696246K983281APOBDFC1999-01-26
1155391571696246K983281APOBDFC1999-01-26
1147081263096791K983221IGGDEW1998-11-04
1155391263096791K983221IGGDEW1998-11-04
1147081361119208K983167TRFDDG1998-11-04
1155391361119208K983167TRFDDG1998-11-04
1147081277809958K983132IGMDFT1998-11-04
1155391277809958K983132IGMDFT1998-11-04
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
1147081479988809K230994Alinity i STAT High Sensitivity Troponin-IMMI2023-05-04
1155391479988809K230994Alinity i STAT High Sensitivity Troponin-IMMI2023-05-04
1155391347155115K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA2023-06-05
3070871347155115K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA2023-06-05
1155391124229904K223602Traumatic brain injury (TBI) testQAT2023-03-02
1147081409163087K223324Total Bilirubin2CIG2022-12-29
1155391409163087K223324Total Bilirubin2CIG2022-12-29
1147081102197463K223317Alkaline Phosphatase2CJE2023-07-21
1155391102197463K223317Alkaline Phosphatase2CJE2023-07-21
1155391823985665K222850HAVAb IgG IILOL2023-08-10
1155391574018327K220949Architect CMV IgGLFZ2022-10-27
1155392019731591K213486GLP systems TrackJGS2022-03-10
3070872019731591K213486GLP systems TrackJGS2022-03-10
1147081942038913K210633Amylase2JFJ2022-05-26
1155391942038913K210633Amylase2JFJ2022-05-26
1155391150106102K210596ARCHITECT Toxo IgGLGD2022-05-19
1147081646036763K210452Creatinine2CGX2022-03-22
1155391646036763K210452Creatinine2CGX2022-03-22
1147082020778306K203597Cholesterol2CHH2022-06-30
1155392020778306K203597Cholesterol2CHH2022-06-30
1147081786443780K203530Albumin BCP2CJW2022-03-18
1155391786443780K203530Albumin BCP2CJW2022-03-18
1147081534300189K203248Albumin BCG2CIX2021-11-23
1155391534300189K203248Albumin BCG2CIX2021-11-23
1147081085569000K202525Alinity i STAT High Sensitivity Troponin-IMMI2022-05-19
1155391085569000K202525Alinity i STAT High Sensitivity Troponin-IMMI2022-05-19
1155391565864493K192118CRP VarioDCK2019-11-08
1147081112874795K191595ARCHITECT STAT High Sensitivity Troponin-IMMI2019-09-13
1155391112874795K191595ARCHITECT STAT High Sensitivity Troponin-IMMI2019-09-13
1155391634694401K190294CELL-DYN Emerald 22 AL SystemGKZ2019-03-15
1147081372859818K181748MagnesiumJGJ2018-09-12
1155391372859818K181748MagnesiumJGJ2018-09-12
1155391734401447K173833CRP VarioNQD2018-09-27
1147081856662227K173122Abbott Architect Free T4CEC2017-10-27
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
1147082037553514K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA2017-10-23
1155392037553514K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA2017-10-23
1155391738223887K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMCFR2017-10-19
1147081439835765K170160Abbott ARCHITECT Free T3JIT2017-02-15
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
1147081307909812K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsMRG2016-08-12
1155391307909812K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsMRG2016-08-12
1147081840620959K151566Abbott ARCHITECT Total T4 CalibratorsJIT2015-07-10
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
1147082062421044K123379ABBOTT ARCHITECT FREE T4CEC2012-11-27
1155392062421044K123379ABBOTT ARCHITECT FREE T4CEC2012-11-27
1155391268567983K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORJIX2013-01-14
1155391206688777K121842ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CLCP2012-12-12
1147081010283374K121314ARCHITECT B12CDD2012-05-17
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
1147082003015212K111023ABBOTT ARCHITECT LH CALIBRATORSJIT2011-06-10
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
1147081655484019K092740ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74CGN2010-03-05
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIT112017-02-15
DHA62023-06-05
MMI62023-05-04
JJY52017-03-31
CDD42024-07-31
CEC42017-10-27
JJX42016-10-26
LOM42012-04-12
CDP41998-11-20
LOL32023-08-10
GKZ32019-03-15
JIX32013-01-14
LCD22025-07-09
LGD22024-08-30
QAT22023-09-29
CJE22023-07-21
CIG22022-12-29
CHH22022-06-30
JFJ22022-05-26
CGX22022-03-22
CJW22022-03-18
JGS22022-03-10
CIX22021-11-23
DCK22019-11-08
JGJ22018-09-12
MRG22016-08-12
PDJ22015-05-22
CDZ22012-09-11
CGN22010-03-05
JZO22006-07-18
JIS22003-04-11
DHR22003-01-15
DER21999-01-29
DFC21999-01-26
DBF21998-12-07
KLI21998-11-25
JLW21998-11-20
CZP21998-11-04
DEW21998-11-04
CZW21998-11-04