Abbott Molecular

FDA Filings

This page includes the latest FDA filings for Abbott Molecular. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3007907438
FEI Number	3007907438
Name	Abbott Molecular
Owner & Operator	ABBOTT LABORATORIES
Contact Address	100 ABBOTT PARK RD. D-03Q3, AP52-1 Abbott Park IL 60064 US
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	Bldg AP01A, Room LL16 100 ABBOTT PARK RD. Abbott Park, IL 60064 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P160044S003 ABBOTT MOLECULAR	Abbott RealTime CMV	2021-03-05
PMA P120012S019 ABBOTT MOLECULAR	Abbott RealTime HCV Genotype II	2021-03-05
PMA P030052S027 ABBOTT MOLECULAR	UroVysion Bladder Cancer Kit	2020-12-11
PMA P030052S026 ABBOTT MOLECULAR	UroVysion Bladder Cancer Kit	2019-08-26
PMA P160044S002 ABBOTT MOLECULAR	Abbott RealTime CMV	2019-05-15
PMA P120012S018 ABBOTT MOLECULAR	Abbott RealTime HCV GT II	2019-05-15
PMA P030052S025 ABBOTT MOLECULAR	UroVysion Bladder Cancer Kit	2019-05-08
PMA P030052S024 ABBOTT MOLECULAR	UroVysion Bladder Cancer Kit	2018-08-29
PMA P030052S023 ABBOTT MOLECULAR	UroVysion Bladder Cancer Kit	2018-07-11
PMA P120012S017 ABBOTT MOLECULAR	Abbott RealTime HCV Genotype II Assay	2018-06-21
PMA P030052S022 ABBOTT MOLECULAR	UroVysion Bladder Cancer Kit	2018-03-12
PMA P030052S021 ABBOTT MOLECULAR	UroVysion Bladder Cancer Kit	2017-12-06
PMA P160044S001 ABBOTT MOLECULAR	Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.	2017-09-01
PMA P120012S016 ABBOTT MOLECULAR	Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit	2017-09-01
PMA P160044 ABBOTT MOLECULAR	ABBOTT REALTIME CMV	2017-05-18
PMA P030052S020 ABBOTT MOLECULAR	Urovysion Bladder Cancer Kit	2017-04-12
PMA P120012S015 ABBOTT MOLECULAR	ABBOTT REALTIME HCV GENOTYPE II	2016-12-23
PMA P030052S019 ABBOTT MOLECULAR	URO VYSION BLADDER CANCER KIT	2016-10-11
PMA P030052S018 ABBOTT MOLECULAR	UROVYSION BLADDER CANCER KIT	2016-09-29
PMN BK130039 \| NHS Abbott Molecular [ABBOTT LABORATORIES]	ViroSeq HIV-1 Genotyping System 04J94-093	2016-09-13
PMN BK130039 \| NHS Abbott Molecular [ABBOTT LABORATORIES]	ViroSeq HIV-1 Genotyping Software adn Algorithm Advisor 04J94-023, Sequencing Consumables Kit 04J94-092,	2016-09-13
PMN BK130039 \| NHS Abbott Molecular [ABBOTT LABORATORIES]	PCR Cleanup Kit 04J94-073	2016-09-13
PMA P120012S014 ABBOTT MOLECULAR	ABBOTT REALTIME HCV GENOTYPE II ASSAY	2016-06-30
PMA P120012S013 ABBOTT MOLECULAR	ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM	2016-06-10
PMA P120012S011 ABBOTT MOLECULAR	ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)	2016-04-20
PMA P120012S012 ABBOTT MOLECULAR	ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)	2016-04-12

Similar & Related FDA Registered Companies

Abbott Molecular, Inc.
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/sterilizer/packager/supplier Expedited Review Granted? No
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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 Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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 Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200924136	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS COMMERCIAL INVOICE NO. 910038600	1080 CTN
20200924136	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS COMMERCIAL INVOICE NO. 910038599	1080 CTN
202009011216	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	ON 10 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS, BLISTER PACKAGING, 2 304 PCS PER C INSTRUMENTS	360 CTN
20200819630	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS COMMERCIAL INVOICE NO. 910040697	540 CTN
202008151085	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS COMMERCIAL INVOICE NO. 910041183	540 CTN
202008151365	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	540 CARTONS ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS, BLISTER PACKAGING, 2 304 PCS PER C INSTRUMENTS	540 PKG
202008151108	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS COMMERCIAL INVOICE NO. 910041188	540 CTN
202008151508	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	540 PACKAGES ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS, BLISTER PACKAGING, 2 304 PCS PER C INSTRUMENTS	540 PKG
202008151505	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	540 CARTONS ON 20 PALLETS DISPOSABLE TIPS CONDUCTIVE 1000UL WITH FILTER FOR GENESIS AND FREEDOM EVO INSTRUMENTS, BLISTER PACKAGING, 2 304 PCS PER C INSTRUMENTS	540 PKG