FDA.reportPublic FDA data

ABBOTT LABORATORIES

Matched from indexed company URL: Abbott Laboratories

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14159391415939ABBOTT LABORATORIES1N2026-01-01100 ABBOTT PARK RD. Abbott Park IL US 60064
14519141451914ABBOTT LABORATORIES1Y2026-01-01U.S. 41/MARTIN LUTHER KING DR. North Chicago IL US 60064
16286641628664ABBOTT LABORATORIES1N2026-01-011921 Hurd Dr IRVING TX US 75038
26300312630031ABBOTT LABORATORIES (PUERTO RICO) INCORPORATED1Y2026-01-019615 Ave Los Romeros Ste 700 San Juan PR US 00926
29190692919069ABBOTT LABORATORIES1N2026-01-01647 Almanor Ave. Sunnyvale CA US 94085
30053333583005333358ABBOTT LABORATORIES1N2026-01-01Conway Park 675 North Field Drive Lake Forest IL US 60045
30064123793006412379Abbott Laboratories (Singapore) Private Limited1N2026-01-013 Fraser Street #23-28 DUO Tower - Central Singapore SG 189352
30164387613016438761ABBOTT LABORATORIES1Y2026-01-011915 Hurd Drive Irving TX US 75038

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
00380740202668Alinity - Alinity s HIV Ag/Ab Combo Calibrator Kit+1(877)422-2688xx@xx.xx
00380740202828Alinity - Alinity s HIV Ag/Ab Combo Assay Control Kit+1(877)422-2688xx@xx.xx
00380740202835Alinity - Alinity s HIV Ag/Ab Combo Release Control Kit+1(877)422-2688xx@xx.xx
00380740202859Alinity - Alinity s HIV Ag/Ab Combo Reagent Kit+1(877)422-2688xx@xx.xx
00380740202996Alinity - Alinity s Chagas Calibrator Kit+1(877)422-2688xx@xx.xx
00380740203023Alinity - Alinity s Chagas Assay Control Kit+1(877)422-2688xx@xx.xx
00380740203030Alinity - Alinity s Chagas Release Control Kit+1(877)422-2688xx@xx.xx
00380740203054Alinity - Alinity s Chagas Reagent Kit+1(877)422-2688xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2333881185492289P980007AXSYM FREE PSAMTG2004-02-05
2333881256468909P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSAMTF1991-09-25
2333881513741180P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitLOM2022-08-10
2333881316120706P120008ABBOTT ARCHITECT AFP ASSAYLOK2012-11-28
2333881238379979P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLSLOM2012-04-12
2333881571913282P080023ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLSSEI2009-04-10
2333881203759096P060035ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSSEI2007-11-06
2333881697919650P050051ABBOTT ARCHITECT AUSABSEI2006-06-01
2333881457975421P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLMZO2006-06-07
20871470727330K991605CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTIONGKZ1999-07-09
2333881946736143K991010ACPCKB1999-05-19
2368861946736143K991010ACPCKB1999-05-19
2333881059413930K990774ABBOTT ARCHITECT CEADHX1999-05-11
2333881919928846K984437QUANTEX ASO-CRP-RP CONTROL IIJJT1999-02-02
2333881757070345K983759ABBOTT ARCHITECT FERRITINDBF1998-12-07
2333881128228408K983442ABBOTT ARCHITECT TSHJLW1998-11-20
2333881632719028K983441C3CZW1998-11-04
2368861632719028K983441C3CZW1998-11-04
2333881596630445K983440ABBOTT ARCHITECT TOTAL T4KLI1998-11-25
2333881138439833K983439ABBOTT ARCHITECT FREE T3CDP1998-11-20
2333881066930130K983434ABBOTT ARCHITECT TOTAL T3CDP1998-11-20
2333881446967412K983424ABBOTT ARCHEITECT TOTAL B-HCGDHA1998-12-01
2333881971712753K983359IGACZP1998-11-04
2368861971712753K983359IGACZP1998-11-04
2333881491571274K983356C4DBI1998-11-04
2368861491571274K983356C4DBI1998-11-04
2333882049809977K983289APOLIPOPROTEIN A1DER1999-01-29
2368862049809977K983289APOLIPOPROTEIN A1DER1999-01-29
2333881571696246K983281APOBDFC1999-01-26
2368861571696246K983281APOBDFC1999-01-26
2333881367077156K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYLFH1998-11-18
2333881263096791K983221IGGDEW1998-11-04
2368861263096791K983221IGGDEW1998-11-04
2333881361119208K983167TRFDDG1998-11-04
2368861361119208K983167TRFDDG1998-11-04
2333881420045196K983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSDKB1998-11-05
2333881277809958K983132IGMDFT1998-11-04
2368861277809958K983132IGMDFT1998-11-04
2333882032722461K983131ASTCIT1998-09-28
2368862032722461K983131ASTCIT1998-09-28
2333882054123542K983070CKCGS1999-02-16
2368862054123542K983070CKCGS1999-02-16
2333882024701941K981918UREACDQ1998-07-28
2368862024701941K981918UREACDQ1998-07-28
2333881456062778K981814ALBPCJW1998-07-22
2368861456062778K981814ALBPCJW1998-07-22
2333881987538662K981791MGJGJ1998-10-23
2368861987538662K981791MGJGJ1998-10-23
2333881698079165K981759PHOSCEO1998-06-16
2368861698079165K981759PHOSCEO1998-06-16
2333881498300620K981758ALBGCIX1998-06-12
2368861498300620K981758ALBGCIX1998-06-12
2333881893827866K981706AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2JIX1998-07-09
2368861893827866K981706AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2JIX1998-07-09
2333881295441304K981682UPROJGQ1998-09-21
2368861295441304K981682UPROJGQ1998-09-21
2333881334989490K981653AMYJFJ1998-08-28
2368861334989490K981653AMYJFJ1998-08-28
2333881015366450K981652CHOLCHH1998-06-29
2368861015366450K981652CHOLCHH1998-06-29
20871331970531K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYGKZ1998-06-29
2333881331970531K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYGKZ1998-06-29
2333881932726554K980367AEROSET SYSTEMCGZ1998-04-01
2368861932726554K980367AEROSET SYSTEMCGZ1998-04-01
2333881975002068K972526METHADONE EIA ASSAYDJR1997-08-04
2333881775889558K971777QUANTEX ASO-CRP-RF CONTROLJJT1997-05-27
2333881233385708K971573N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SETLBR1997-06-18
2333882056020146K961393TRICYCLICS SERUM TOX ASSAYLFH1996-06-12
2333881225407426K961372SERUM TOX CALIBRATORDKB1996-05-01
2333881506287481K960708BENZODIAZEPINE SERUM TOX EIA TESTJXM1996-05-20
2333882017668346K960664BARBITURATE SERUM TOX EIA ASSAYDIS1996-05-06
2333882015631111K960187COCAINE METABOLITE EIA TESTDIO1996-04-02
2333881643046727K955928BARBITURATE EIA ESSAY (MODIFICATION)DIS1996-03-11
2333882063645011K953971TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGYCDT1996-04-05
2333881128814055K952596THEOPHYLLINE ENZYME IMMUNOASSAYKLS1995-08-11
2333881050969913K945725PHENYTION EIA TESTDIP1995-02-03
2333881254341894K943998CANNABINOID EIA ASSAYLDJ1994-11-04
2333881131783266K943414PROPOXPHENE EIA TESTJXN1994-09-09
2333881994459409K940935URINE CALIBRATORDKB1994-07-06
2333881224613904K935320PHENCYCLIDINE EIA ASSAYLCM1993-12-29
2333881218803758K934891AMPHETAMINES EIA ASSAY MODIFICATIONDKZ1994-01-13
2333881168262186K934667METHADONE ENZYME IMMUNOASSAYDJR1994-01-26
2333881551408659K932113CANNABINOID URINE CONTROLSJJX1993-06-29
2333881938498396K930529BENZODIAZEPINE ENZYME IMMUNOASSAYJXM1993-08-05
2333882043452600K924733ETHYL ALCOHOL CALIBRATORS & CONTROLDNN1992-12-09
2333882049127414K923783ETHYL ALCOHOL ASSAYDMT1993-01-21
2333881331461268K923386THC URINE CALIBRATORSDLJ1992-09-14
2333881426539331K903101INNOFLUOR (TM) AMIKACIN CALIBRATOR SETDLJ1990-08-22
20871571043282K901875PARA 12 PLUSJCN1990-05-30
2333881571043282K901875PARA 12 PLUSJCN1990-05-30
2333882057235950K894486QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)GTQ1989-10-24
2333881918620013K892212INNOFLUOR(TM) QUINDINE CALIBATOR SETDLJ1989-06-09
2333881894489964K872349INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SETDLJ1987-07-21
20871567794589K840261CAL-CHEX, A HEMATOLOGY CALIBRATORKRZ1984-02-21
2333881567794589K840261CAL-CHEX, A HEMATOLOGY CALIBRATORKRZ1984-02-21
20871821768400K823498PARA 12GLQ1982-12-28
2333881821768400K823498PARA 12GLQ1982-12-28
2333881110591424K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF2025-02-12
2333881309798336K243500ARCHITECT iGentamicinLCD2025-07-09
20871095503250K243283Alinity h-series SystemGKZ2025-02-20
1915331095503250K243283Alinity h-series SystemGKZ2025-02-20
2333881095503250K243283Alinity h-series SystemGKZ2025-02-20
2368861095503250K243283Alinity h-series SystemGKZ2025-02-20
2333881502685312K243168Alinity i Rubella IgGLFX2025-06-20
2333881926482337K242585Cystatin CNDY2025-05-16
2333881116478964K233932Alinity i Toxo IgMLGD2024-08-30
2333881550578796K233541ARCHITECT Active-B12 (Holotranscobalamin)CDD2024-07-31
2333881378319410K232669TBIQAT2023-09-29
2333881029065345K231020Alinity c Tricyclic Antidepressants Reagent KitLFH2023-11-17
2333881479988809K230994Alinity i STAT High Sensitivity Troponin-IMMI2023-05-04
2333881347155115K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA2023-06-05
2333881729677734K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesDHA2023-05-19
2368861729677734K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesDHA2023-05-19
2333881124229904K223602Traumatic brain injury (TBI) testQAT2023-03-02
2333881409163087K223324Total Bilirubin2CIG2022-12-29
2333881102197463K223317Alkaline Phosphatase2CJE2023-07-21
2333881823985665K222850HAVAb IgG IILOL2023-08-10
2333881574018327K220949Architect CMV IgGLFZ2022-10-27
20871353985901K220031Alinity h-series SystemGKZ2023-08-04
1915331353985901K220031Alinity h-series SystemGKZ2023-08-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ312025-02-20
DHA82023-06-05
JIT82017-02-15
JIX82013-01-14
CIG72022-12-29
GLQ72011-12-22
JJY62017-03-31
CFR52017-10-19
JJX52016-10-26
CDZ52015-12-17
KRX52011-12-22
DLJ52001-08-27
MMI42023-05-04
JGJ42018-09-12
CGZ42017-10-24
PDJ42015-05-22
LOM42012-04-12
CIT42008-03-19
LCD32025-07-09
CDD32024-07-31
LFH32023-11-17
LOL32023-08-10
CJE32023-07-21
CHH32022-06-30
JFJ32022-05-26
CGX32022-03-22
CJW32022-03-18
CIX32021-11-23
JXM32018-02-21
DIF32013-09-20
LEH32013-08-29
DKZ32010-05-12
DFC32005-04-26
DKB31998-11-05
LGD22024-08-30
QAT22023-09-29
DGC22023-02-21
LDP22022-02-18
DCK22019-11-08
DIO22018-07-06

PMA#

ARCHITECT Total PSA / Alinity i Total PSA

2023-01-27

Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS059 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufactur...

ARCHITECT CORE-M / Alinity i Anti-HBc IgM

2023-01-27

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS037 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process...

ARCHITECT AFP / Alinity i AFP

2023-01-27

Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS021 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Pr...

ARCHITECT CORE / Alinity i Anti-HBc

2023-01-27

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS039 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...

ARCHITECT Free PSA / Alinity i Free PSA

2023-01-27

Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS048 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Cha...

ARCHITECT AUSAB / Alinity i Anti-HBs

2023-01-27

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS049 Date Received01/06/2023 Decision Date01/27/2023 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

ARCHITECT HBsAg Next Qualitative / Next Confirmatory

2023-01-27

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS005 Date Received01/06/2023 Decision Date01/27/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process...

ARCHITECT HBsAg Next Qualitative/Next Confirmatory

2022-12-07

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT AUSAB/Alinity i Anti-HBs

2022-12-07

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS048 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

Alinity i Anti-HBc (List Number 07P84)

2022-10-25

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS038 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement R...

Alinity i Anti-HBc IgM (List Number 07P86)

2022-10-25

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS036 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT AFP / Alinity i AFP

2022-10-12

Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS020 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Pr...

ARCHITECT AUSAB / Alinity i Anti-HBs

2022-10-12

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory

2022-10-12

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS002 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT CORE / Alinity i Anti-HBc

2022-10-12

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS037 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement R...

ARCHITECT CORE-M / Alinity i Anti-HBc IgM

2022-10-12

Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS035 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

ARCHITECT Free PSA / Alinity i Free PSA

2022-10-12

Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Notice Supplement ...

ARCHITECT Total PSA / Alinity i Total PSA

2022-10-12

Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS058 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process C...

ARCHITECT AUSAB / Alinity i Anti-HBs

2022-09-30

ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS046 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement...

ARCHITECT HBsAg Next Qualitative/ Next Confirmatory

2022-09-30

Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS001 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplem...

200 records. Showing 1-40. Next

PMN#

TBI

2023-09-29

Abbott Laboratories

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next