FDA.reportPublic FDA data

ABBOTT MOLECULAR, INC.

Matched from indexed company URL: Abbott Molecular

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30052481923005248192ABBOTT MOLECULAR, INC.1Y2026-01-011300 EAST TOUHY AVENUE Des Plaines IL US 60018
30198379623019837962Abbott Molecular Distribution Center1Y2026-01-011015 West Devon Itasca IL US 60143
30079074383007907438Abbott Molecular1N2020-04-25Bldg AP01A, Room LL16 100 ABBOTT PARK RD. Abbott Park IL US 60064
30099684733009968473Abbott Molecular, Inc.1Y2020-04-251800 Brummel Ave Elk Grove Village IL US 60007

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
00884999047426Alinity m - Alinity m Waste Box+1(800)553-7042customerservice@abbottmolecular.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
21651607502001P980024PATHVYSION HER-2 DNA PROBE KITMVD1998-12-11
21651111492234P230003Alinity m HR HPVMAQ2023-11-01
2948481111492234P230003Alinity m HR HPVMAQ2023-11-01
21651587924514P210022Alinity m CMVPAB2022-05-05
2948481587924514P210022Alinity m CMVPAB2022-05-05
21651552575489P200013Alinity m HBVMKT2020-08-29
21651805965732P190025Alinity m HCVMZP2020-03-23
2948481805965732P190025Alinity m HCVMZP2020-03-23
21651252645802P170041Abbott RealTime IDH1OWD2018-07-20
21651251071338P170005Abbott RealTime IDH2OWD2017-08-01
21652040089977P160044ABBOTT REALTIME CMVPAB2017-05-18
2948482040089977P160044ABBOTT REALTIME CMVPAB2017-05-18
21651607306097P150041VYSIS CLL FISH PROBE KITPNK2016-04-11
2948481607306097P150041VYSIS CLL FISH PROBE KITPNK2016-04-11
21651298217069P120012ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)OBF2013-06-20
21651913746976P110012VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKOWE2011-08-26
2948481913746976P110012VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKOWE2011-08-26
21651537117142P100017ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCVMZP2011-05-17
21651691443633P080026ABBOTT REALTIME HBV ASSAYMKT2010-08-13
21651436424352P030052UROVYSION BLADDER CANCER KIT2005-01-24
2948481436424352P030052UROVYSION BLADDER CANCER KIT2005-01-24
21651705828669K962873CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBEOVQ1997-01-13
21651050477089K954214CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITOXP1997-01-21
21651951099209K953591CEP 8 SPECTRUMORANGE DNA PROBE KITOYU1996-11-29
21651996107148K243410simpli-COLLECT STI TestQYA2025-01-30
21651491137219K241921Alinity m BKVQMI2025-03-24
21651941339185K241573Alinity m Resp-4-PlexQOF2025-02-14
2948481941339185K241573Alinity m Resp-4-PlexQOF2025-02-14
21651485500074K233349Alinity m HSV 1 & 2 / VZVPGI2024-05-03
21651198000596K222379Alinity m STI AssayQEP2023-03-03
2948481198000596K222379Alinity m STI AssayQEP2023-03-03
21652045324722K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)QLX2022-07-15
21651200101773K202977Alinity m STI AssayQEP2022-04-29
2948481200101773K202977Alinity m STI AssayQEP2022-04-29
21651349259325K140354ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGLSL2014-05-09
2948481349259325K140354ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGLSL2014-05-09
21651841823802K140198IMDX HSV-1/2 FOR ABBOTT M2000OQO2014-05-13
21651831209251K131584IMDX FLU A/B AND RSV FOR ABBOTT M2000OCC2013-08-21
21651194652361K131508VYSIS D7S486/CEP 7 FISH PROBE KITPFG2013-09-13
2948481194652361K131508VYSIS D7S486/CEP 7 FISH PROBE KITPFG2013-09-13
21651584288253K100015VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34OVQ2011-08-09
21651681248482K092705ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501OOI2010-05-28
21651175598002K091960VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020OWK2011-08-29
21651461115465K080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITMKZ2008-07-10
2948481461115465K080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITMKZ2008-07-10
21651623294705K010288ANEUVYSION MULITICOLOR DNA PROBE KITOYU2001-04-13
2948481623294705K010288ANEUVYSION MULITICOLOR DNA PROBE KITOYU2001-04-13
21651611379840DEN130010VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)PDO2013-07-29
2948481611379840DEN130010VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)PDO2013-07-29
21651609377162DEN040010VYSIS AUTOVYSION SYSTEMNTH2004-12-13
21651466844139BP200455
21651261225755BP060002
2948481261225755BP060002
21651830684106BK130039
1985931830684106BK130039
21651249457780
21651416982960
21651547656267
21651900158661
21651000247602
2948481000247602
21651037720488
21651065945321
2948481065945321
21651077458425
2948481077458425
21651091700756
2948481091700756
21651101137721
21651120778147
2948481120778147
21651122655096
21651164659802
2948481164659802
21651246559055
21651250210257
2948481250210257
21651265192763
21651287176430
21651339776668
21651428855341
2948481428855341
21651431575021
2948481431575021
21651441172427
21651476742266
2948481476742266
21651478731904
21651522200790
2948481547656267
21651626575308
2948481626575308
21651751965150
2948481751965150
21651818271963
21651839834389
2948481839834389
21651851408277
21651857320796
2948481857320796
21651971168791
2948481971168791
21652006216459
2948482006216459
21652026792790
2948482026792790
21652040859643
21652046376628
21652072800468

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEP42023-03-03
OYU32001-04-13
QOF22025-02-14
PAB 22022-05-05
OWD22018-07-20
PAB22017-05-18
PNK22016-04-11
LSL22014-05-09
PFG22013-09-13
PDO22013-07-29
OWE22011-08-26
OVQ22011-08-09
MKZ22008-07-10
QMI12025-03-24
QYA12025-01-30
PGI12024-05-03
QLX12022-07-15
MKT 12020-08-29
OQO12014-05-13
OCC12013-08-21
OBF12013-06-20
OWK12011-08-29
MZP12011-05-17
MKT12010-08-13
OOI12010-05-28
NTH12004-12-13
MVD11998-12-11
OXP11997-01-21

PMA#

Alinity m HBV Assay

2023-01-13

Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS012 Date Received12/20/2022 Decision Date01/13/2023 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/...

RealTime CMV Assay

2023-01-13

ABBOTT MOLECULAR1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP160044 Supplement NumberS005 Date Received12/20/2022 Decision Date01/13/2023 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...

Alinity m HBV

2022-12-22

Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS011 Date Received12/07/2022 Decision Date12/22/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason ...

Alinity m CMV

2022-11-28

Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Supplement NumberS002 Date Received11/03/2022 Decision Date11/28/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process ...

Alinity m HBV

2022-10-24

Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS009 Date Received09/21/2022 Decision Date10/24/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason ...

Alinity m HBV

2022-06-08

Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS008 Date Received05/10/2022 Decision Date06/08/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...

Alinity m CMV

2022-05-26

Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Supplement NumberS001 Date Received05/18/2022 Decision Date05/26/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process ...

Alinity m CMV

2022-05-05

Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Date Received06/01/2021 Decision Date05/05/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No

UroVysion Bladder Cancer Kit

2022-03-18

ABBOTT MOLECULAR1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP030052 Supplement NumberS028 Date Received02/18/2022 Decision Date03/18/2022 Product Code NSD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - ...

PathVysion HER-2 DNA Probe Kit

2022-03-18

ABBOTT MOLECULAR, INC.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP980024 Supplement NumberS022 Date Received02/18/2022 Decision Date03/18/2022 Product Code MVD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process C...

Alinity m HBV

2022-03-14

Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS006 Date Received02/17/2022 Decision Date03/14/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...

183 records. Showing 1-40. Next

PMN#

GUDID#

80 records. Showing 1-40. Next