ABBOTT MOLECULAR, INC.
Matched from indexed company URL: Abbott Molecular
FDA Registration(s)#
Registration, FEI, Name table| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|
| 3005248192 | 3005248192 | ABBOTT MOLECULAR, INC. | 1 | Y | 2026-01-01 | 1300 EAST TOUHY AVENUE Des Plaines IL US 60018 |
| 3019837962 | 3019837962 | Abbott Molecular Distribution Center | 1 | Y | 2026-01-01 | 1015 West Devon Itasca IL US 60143 |
| 3007907438 | 3007907438 | Abbott Molecular | 1 | N | 2020-04-25 | Bldg AP01A, Room LL16 100 ABBOTT PARK RD. Abbott Park IL US 60064 |
| 3009968473 | 3009968473 | Abbott Molecular, Inc. | 1 | Y | 2020-04-25 | 1800 Brummel Ave Elk Grove Village IL US 60007 |
Registered Device Listings#
Registration key, Listing key, Premarket submission table| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|
| 2165 | 1607502001 | P980024 | PATHVYSION HER-2 DNA PROBE KIT | MVD | 1998-12-11 |
| 2165 | 1111492234 | P230003 | Alinity m HR HPV | MAQ | 2023-11-01 |
| 294848 | 1111492234 | P230003 | Alinity m HR HPV | MAQ | 2023-11-01 |
| 2165 | 1587924514 | P210022 | Alinity m CMV | PAB | 2022-05-05 |
| 294848 | 1587924514 | P210022 | Alinity m CMV | PAB | 2022-05-05 |
| 2165 | 1552575489 | P200013 | Alinity m HBV | MKT | 2020-08-29 |
| 2165 | 1805965732 | P190025 | Alinity m HCV | MZP | 2020-03-23 |
| 294848 | 1805965732 | P190025 | Alinity m HCV | MZP | 2020-03-23 |
| 2165 | 1252645802 | P170041 | Abbott RealTime IDH1 | OWD | 2018-07-20 |
| 2165 | 1251071338 | P170005 | Abbott RealTime IDH2 | OWD | 2017-08-01 |
| 2165 | 2040089977 | P160044 | ABBOTT REALTIME CMV | PAB | 2017-05-18 |
| 294848 | 2040089977 | P160044 | ABBOTT REALTIME CMV | PAB | 2017-05-18 |
| 2165 | 1607306097 | P150041 | VYSIS CLL FISH PROBE KIT | PNK | 2016-04-11 |
| 294848 | 1607306097 | P150041 | VYSIS CLL FISH PROBE KIT | PNK | 2016-04-11 |
| 2165 | 1298217069 | P120012 | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) | OBF | 2013-06-20 |
| 2165 | 1913746976 | P110012 | VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK | OWE | 2011-08-26 |
| 294848 | 1913746976 | P110012 | VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK | OWE | 2011-08-26 |
| 2165 | 1537117142 | P100017 | ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV | MZP | 2011-05-17 |
| 2165 | 1691443633 | P080026 | ABBOTT REALTIME HBV ASSAY | MKT | 2010-08-13 |
| 2165 | 1436424352 | P030052 | UROVYSION BLADDER CANCER KIT | | 2005-01-24 |
| 294848 | 1436424352 | P030052 | UROVYSION BLADDER CANCER KIT | | 2005-01-24 |
| 2165 | 1705828669 | K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | OVQ | 1997-01-13 |
| 2165 | 1050477089 | K954214 | CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT | OXP | 1997-01-21 |
| 2165 | 1951099209 | K953591 | CEP 8 SPECTRUMORANGE DNA PROBE KIT | OYU | 1996-11-29 |
| 2165 | 1996107148 | K243410 | simpli-COLLECT STI Test | QYA | 2025-01-30 |
| 2165 | 1491137219 | K241921 | Alinity m BKV | QMI | 2025-03-24 |
| 2165 | 1941339185 | K241573 | Alinity m Resp-4-Plex | QOF | 2025-02-14 |
| 294848 | 1941339185 | K241573 | Alinity m Resp-4-Plex | QOF | 2025-02-14 |
| 2165 | 1485500074 | K233349 | Alinity m HSV 1 & 2 / VZV | PGI | 2024-05-03 |
| 2165 | 1198000596 | K222379 | Alinity m STI Assay | QEP | 2023-03-03 |
| 294848 | 1198000596 | K222379 | Alinity m STI Assay | QEP | 2023-03-03 |
| 2165 | 2045324722 | K212778 | Alinity 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) | QLX | 2022-07-15 |
| 2165 | 1200101773 | K202977 | Alinity m STI Assay | QEP | 2022-04-29 |
| 294848 | 1200101773 | K202977 | Alinity m STI Assay | QEP | 2022-04-29 |
| 2165 | 1349259325 | K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | LSL | 2014-05-09 |
| 294848 | 1349259325 | K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | LSL | 2014-05-09 |
| 2165 | 1841823802 | K140198 | IMDX HSV-1/2 FOR ABBOTT M2000 | OQO | 2014-05-13 |
| 2165 | 1831209251 | K131584 | IMDX FLU A/B AND RSV FOR ABBOTT M2000 | OCC | 2013-08-21 |
| 2165 | 1194652361 | K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT | PFG | 2013-09-13 |
| 294848 | 1194652361 | K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT | PFG | 2013-09-13 |
| 2165 | 1584288253 | K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 | OVQ | 2011-08-09 |
| 2165 | 1681248482 | K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | OOI | 2010-05-28 |
| 2165 | 1175598002 | K091960 | VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 | OWK | 2011-08-29 |
| 2165 | 1461115465 | K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | MKZ | 2008-07-10 |
| 294848 | 1461115465 | K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | MKZ | 2008-07-10 |
| 2165 | 1623294705 | K010288 | ANEUVYSION MULITICOLOR DNA PROBE KIT | OYU | 2001-04-13 |
| 294848 | 1623294705 | K010288 | ANEUVYSION MULITICOLOR DNA PROBE KIT | OYU | 2001-04-13 |
| 2165 | 1611379840 | DEN130010 | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) | PDO | 2013-07-29 |
| 294848 | 1611379840 | DEN130010 | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) | PDO | 2013-07-29 |
| 2165 | 1609377162 | DEN040010 | VYSIS AUTOVYSION SYSTEM | NTH | 2004-12-13 |
| 2165 | 1466844139 | BP200455 | | | |
| 2165 | 1261225755 | BP060002 | | | |
| 294848 | 1261225755 | BP060002 | | | |
| 2165 | 1830684106 | BK130039 | | | |
| 198593 | 1830684106 | BK130039 | | | |
| 2165 | 1249457780 | | | | |
| 2165 | 1416982960 | | | | |
| 2165 | 1547656267 | | | | |
| 2165 | 1900158661 | | | | |
| 2165 | 1000247602 | | | | |
| 294848 | 1000247602 | | | | |
| 2165 | 1037720488 | | | | |
| 2165 | 1065945321 | | | | |
| 294848 | 1065945321 | | | | |
| 2165 | 1077458425 | | | | |
| 294848 | 1077458425 | | | | |
| 2165 | 1091700756 | | | | |
| 294848 | 1091700756 | | | | |
| 2165 | 1101137721 | | | | |
| 2165 | 1120778147 | | | | |
| 294848 | 1120778147 | | | | |
| 2165 | 1122655096 | | | | |
| 2165 | 1164659802 | | | | |
| 294848 | 1164659802 | | | | |
| 2165 | 1246559055 | | | | |
| 2165 | 1250210257 | | | | |
| 294848 | 1250210257 | | | | |
| 2165 | 1262162702 | | | | |
| 2165 | 1265192763 | | | | |
| 2165 | 1287176430 | | | | |
| 2165 | 1339776668 | | | | |
| 2165 | 1428855341 | | | | |
| 294848 | 1428855341 | | | | |
| 2165 | 1431575021 | | | | |
| 294848 | 1431575021 | | | | |
| 2165 | 1441172427 | | | | |
| 2165 | 1476742266 | | | | |
| 294848 | 1476742266 | | | | |
| 2165 | 1478731904 | | | | |
| 2165 | 1522200790 | | | | |
| 294848 | 1547656267 | | | | |
| 2165 | 1626575308 | | | | |
| 294848 | 1626575308 | | | | |
| 2165 | 1640856218 | | | | |
| 2165 | 1751965150 | | | | |
| 294848 | 1751965150 | | | | |
| 2165 | 1818271963 | | | | |
| 2165 | 1839834389 | | | | |
| 294848 | 1839834389 | | | | |
| 2165 | 1851408277 | | | | |
| 2165 | 1857320796 | | | | |
| 294848 | 1857320796 | | | | |
| 2165 | 1971168791 | | | | |
| 294848 | 1971168791 | | | | |
| 2165 | 2006216459 | | | | |
| 294848 | 2006216459 | | | | |
| 2165 | 2026792790 | | | | |
| 294848 | 2026792790 | | | | |
| 2165 | 2040859643 | | | | |
| 2165 | 2046376628 | | | | |
| 2165 | 2072800468 | | | | |
Product Codes Associated With Registrations#
Product code, Registration listing records, Latest decision table| Product code | Registration listing records | Latest decision |
|---|
| QEP | 4 | 2023-03-03 |
| OYU | 3 | 2001-04-13 |
| QOF | 2 | 2025-02-14 |
| PAB | 2 | 2022-05-05 |
| OWD | 2 | 2018-07-20 |
| PAB | 2 | 2017-05-18 |
| PNK | 2 | 2016-04-11 |
| LSL | 2 | 2014-05-09 |
| PFG | 2 | 2013-09-13 |
| PDO | 2 | 2013-07-29 |
| OWE | 2 | 2011-08-26 |
| OVQ | 2 | 2011-08-09 |
| MKZ | 2 | 2008-07-10 |
| QMI | 1 | 2025-03-24 |
| QYA | 1 | 2025-01-30 |
| PGI | 1 | 2024-05-03 |
| QLX | 1 | 2022-07-15 |
| MKT | 1 | 2020-08-29 |
| OQO | 1 | 2014-05-13 |
| OCC | 1 | 2013-08-21 |
| OBF | 1 | 2013-06-20 |
| OWK | 1 | 2011-08-29 |
| MZP | 1 | 2011-05-17 |
| MKT | 1 | 2010-08-13 |
| OOI | 1 | 2010-05-28 |
| NTH | 1 | 2004-12-13 |
| MVD | 1 | 1998-12-11 |
| OXP | 1 | 1997-01-21 |
PMA#
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/...
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...
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 ...
2022-12-01
Abbott Molecular, Inc.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP170041 Supplement NumberS006 Date Received12/17/2021 Decision Date12/01/2022 Product Code OWD Advisory Committee Clinical TrialsNCT02719574 Supplement Typenormal 180 Day Track Sup...
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 ...
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 ...
2022-06-09
ABBOTT MOLECULAR1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP160044 Supplement NumberS004 Date Received05/19/2022 Decision Date06/09/2022 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chan...
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...
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 ...
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
2022-04-11
Abbott Molecular Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP170005 Supplement NumberS004 Date Received03/10/2022 Decision Date04/11/2022 Product Code OWD Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Process Ch...
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 - ...
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...
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...
2021-06-01
Abbott Molecular, Inc.
2021-06-01
Abbott Molecular, Inc.
2021-03-08
Abbott Molecular, Inc.
2021-03-05
ABBOTT MOLECULAR, INC.
2021-03-05
ABBOTT MOLECULAR
2021-03-05
ABBOTT MOLECULAR, INC.
2021-03-05
ABBOTT MOLECULAR
2021-03-05
Abbott Molecular, Inc.
2021-03-05
Abbott Molecular, Inc.
2021-03-03
Abbott Molecular Inc.
2021-03-03
Abbott Molecular, Inc.
2021-01-19
Abbott Molecular, Inc.
2021-01-19
Abbott Molecular, Inc.
2021-01-19
Abbott Molecular Inc.
2021-01-19
Abbott Molecular, Inc.
2020-12-11
ABBOTT MOLECULAR
2020-12-11
ABBOTT MOLECULAR, INC.
2020-12-11
ABBOTT MOLECULAR, INC.
2020-12-11
ABBOTT MOLECULAR, INC.
2020-12-08
ABBOTT MOLECULAR, INC.
2020-12-04
ABBOTT MOLECULAR, INC.
2020-08-29
Abbott Molecular, Inc.
2020-06-09
Abbott Molecular, Inc.
2020-05-22
ABBOTT MOLECULAR, INC.
2020-05-06
Abbott Molecular, Inc.
2020-03-23
Abbott Molecular, Inc.
183 records. Showing 1-40. Next
PMN#
2025-03-24
Abbott Molecular, Inc.
2025-02-14
Abbott Molecular, Inc.
2025-01-30
Abbott Molecular
2024-12-06
Abbott Molecular
2024-05-03
Abbott Molecular, Inc.
2023-03-03
Abbott Molecular, Inc.
2022-07-15
Abbott Molecular, Inc.
2022-04-29
Abbott Molecular, Inc.
2014-05-09
ABBOTT MOLECULAR, INC.
2013-09-13
ABBOTT MOLECULAR, INC.
2011-08-29
ABBOTT MOLECULAR, INC.
2011-08-09
ABBOTT MOLECULAR, INC.
2010-05-28
ABBOTT MOLECULAR, INC.
2010-05-28
ABBOTT MOLECULAR, INC.
2008-07-10
ABBOTT MOLECULAR, INC.
GUDID#
ABBOTT MOLECULAR INC.
2026-07-06
ABBOTT MOLECULAR INC.
2026-07-06
ABBOTT MOLECULAR INC.
2026-04-13
ABBOTT MOLECULAR INC.
2026-04-13
ABBOTT MOLECULAR INC.
2025-11-20
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2020-04-29
ABBOTT MOLECULAR INC.
2016-09-01
ABBOTT MOLECULAR INC.
2020-08-18
ABBOTT MOLECULAR INC.
2025-06-27
ABBOTT MOLECULAR INC.
2025-06-27
ABBOTT MOLECULAR INC.
2025-06-27
ABBOTT MOLECULAR INC.
2025-06-26
ABBOTT MOLECULAR INC.
2025-06-26
ABBOTT MOLECULAR INC.
2025-06-26
ABBOTT MOLECULAR INC.
2025-06-26
ABBOTT MOLECULAR INC.
2025-05-30
ABBOTT MOLECULAR INC.
2025-05-30
ABBOTT MOLECULAR INC.
2025-05-30
ABBOTT MOLECULAR INC.
2025-05-30
ABBOTT MOLECULAR INC.
2025-05-28
ABBOTT MOLECULAR INC.
2025-05-28
ABBOTT MOLECULAR INC.
2025-05-28
ABBOTT MOLECULAR INC.
2025-05-28
ABBOTT MOLECULAR INC.
2025-05-28
ABBOTT MOLECULAR INC.
2017-12-15
ABBOTT MOLECULAR INC.
2017-12-15
ABBOTT MOLECULAR INC.
2020-05-04
ABBOTT MOLECULAR INC.
2020-05-08
ABBOTT MOLECULAR INC.
2020-09-09
ABBOTT MOLECULAR INC.
2020-09-23
ABBOTT MOLECULAR INC.
2020-09-23
ABBOTT MOLECULAR INC.
2021-03-10
80 records. Showing 1-40. Next