Exact Sciences Corp

FDA Filings

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

USA

NASDAQ

EXAS

DUNS 150908853

FDA Registration(s)

• Registration Number: 3008256118
• FEI Number: 3008256118
• Name: Exact Sciences Corporation
• Owner & Operator: Exact Sciences Corp
• Contact Address: 441 Charmany Drive ; Madison WI 53719 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 441 Charmany Dr ; Madison, WI 53719 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

• Registration Number: 3013841562
• FEI Number: 3013841562
• Name: EXACT SCIENCES CORP
• Owner & Operator: Exact Sciences Corp
• Contact Address: 441 Charmany Drive ; Madison WI 53719 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 320 Holtzman Road ; Madison, WI 53713 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3015728010
• FEI Number: 3015728010
• Name: Exact Sciences, Corporation
• Owner & Operator: Exact Sciences Corp
• Contact Address: 441 Charmany Drive ; Madison WI 53719 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 650 Forward Dr ; Madison, WI 53711 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00858637005949 EXACT SCIENCES CORPORATION	The Cologuard Plus Collection Kit	2025-03-27
GUDID 00858637005901 EXACT SCIENCES CORPORATION	Cologuard 2 Test Definition	2025-03-27
GUDID 00858637005888 EXACT SCIENCES CORPORATION	Cologuard Test Definition v1.7	2025-03-27
GUDID 00858637005871 EXACT SCIENCES CORPORATION	Cycler Control v2.2	2025-03-27
GUDID 00858637005864 EXACT SCIENCES CORPORATION	STARlet Interface v2.2	2025-03-27
GUDID 00858637005857 EXACT SCIENCES CORPORATION	Analysis Client v2.2	2025-03-27
GUDID 00858637005840 EXACT SCIENCES CORPORATION	Analysis Server v2.2	2025-03-27
GUDID 00858637005994 EXACT SCIENCES CORPORATION	Hemoglobin Bead Controls SLIB Goup Kit	2025-02-27
GUDID 00858637005987 EXACT SCIENCES CORPORATION	Hemoglobin Bead Based Assay Reagents SLIB Group Kit	2025-02-27
GUDID 00858637005970 EXACT SCIENCES CORPORATION	DNA Controls SLIB Group Kit	2025-02-27
GUDID 00858637005963 EXACT SCIENCES CORPORATION	DNA and LQAS Reagent SLIB Group Kit	2025-02-27
GUDID 00858637005925 EXACT SCIENCES CORPORATION	CG2 WSH	2025-02-27
GUDID 00858637005918 EXACT SCIENCES CORPORATION	CG2 CNV WSH	2025-02-27
GUDID 00850057859034 EXACT SCIENCES CORPORATION	CG2 REC BFR	2025-02-27
GUDID 00850057859027 EXACT SCIENCES CORPORATION	CG2 BND SLN	2025-02-27
GUDID 00850057859010 EXACT SCIENCES CORPORATION	CG2 CAP WSH	2025-02-27
GUDID 00850057859003 EXACT SCIENCES CORPORATION	CG2 CAP BDS	2025-02-27
GUDID 00858637005345 EXACT SCIENCES CORPORATION	CAP SLN	2024-11-28
GUDID 00858637005833 EXACT SCIENCES CORPORATION	Reader Control v2.2	2024-05-03
GUDID 00858637005932 EXACT SCIENCES CORPORATION	Cologuard FILT	2024-02-02
GUDID 00858637005338 EXACT SCIENCES CORPORATION	Cologuard STL BFR	2024-02-02
PMA P130017S050 Exact Sciences Corporation	Cologuard®	2021-12-13
PMA P130017S049 Exact Sciences Corporation	Cologuard	2021-10-06
GUDID 00858637005703 EXACT SCIENCES CORPORATION	HB CTRL 3 Kit	2021-09-06
GUDID 00858637005697 EXACT SCIENCES CORPORATION	HB CTRL 2 Kit	2021-09-06
GUDID 00858637005680 EXACT SCIENCES CORPORATION	HB CTRL 1 Kit	2021-09-06
GUDID 00858637005673 EXACT SCIENCES CORPORATION	DIL BFR Kit	2021-09-06
GUDID 00858637005666 EXACT SCIENCES CORPORATION	HB CAL Kit	2021-09-06
GUDID 00858637005659 EXACT SCIENCES CORPORATION	SUBS Kit	2021-09-06
GUDID 00858637005642 EXACT SCIENCES CORPORATION	CONJ Kit	2021-09-06
GUDID 00858637005635 EXACT SCIENCES CORPORATION	STP SLN Kit	2021-09-06
GUDID 00858637005628 EXACT SCIENCES CORPORATION	HB CAP BEAD Kit	2021-09-06
GUDID 00858637005611 EXACT SCIENCES CORPORATION	CNV WSH Kit	2021-09-06
GUDID 00858637005604 EXACT SCIENCES CORPORATION	PRE WSH Kit	2021-09-06
GUDID 00858637005598 EXACT SCIENCES CORPORATION	DEN SLN Kit	2021-09-06
GUDID 00858637005581 EXACT SCIENCES CORPORATION	BND BDS Kit	2021-09-06
GUDID 00858637005574 EXACT SCIENCES CORPORATION	BIS SLN Kit	2021-09-06
GUDID 00858637005567 EXACT SCIENCES CORPORATION	NEU SLN Kit	2021-09-06
GUDID 00858637005550 EXACT SCIENCES CORPORATION	DES SLN Kit	2021-09-06
GUDID 00858637005543 EXACT SCIENCES CORPORATION	CAP BDS Kit	2021-09-06
GUDID 00858637005536 EXACT SCIENCES CORPORATION	ELU BFR Kit	2021-09-06
GUDID 00858637005529 EXACT SCIENCES CORPORATION	CAR SLN Kit	2021-09-06
GUDID 00858637005512 EXACT SCIENCES CORPORATION	MIX B Kit	2021-09-06
GUDID 00858637005505 EXACT SCIENCES CORPORATION	MIX A Kit	2021-09-06
GUDID 00858637005499 EXACT SCIENCES CORPORATION	ENZ Kit	2021-09-06
GUDID 00858637005482 EXACT SCIENCES CORPORATION	D CAL 4 Kit	2021-09-06
GUDID 00858637005475 EXACT SCIENCES CORPORATION	D CAL 3 Kit	2021-09-06
GUDID 00858637005468 EXACT SCIENCES CORPORATION	D CAL 2 Kit	2021-09-06
GUDID 00858637005451 EXACT SCIENCES CORPORATION	D CAL 1 Kit	2021-09-06
GUDID 00858637005444 EXACT SCIENCES CORPORATION	D CTRL 3 Kit	2021-09-06
GUDID 00858637005437 EXACT SCIENCES CORPORATION	D CTRL 2 Kit	2021-09-06
GUDID 00858637005420 EXACT SCIENCES CORPORATION	D CTRL 1 Kit	2021-09-06
GUDID 00858637005826 EXACT SCIENCES CORPORATION	Cologuard Test Definition v1.6	2021-06-08
PMA P130017S048 Exact Sciences Corporation	Cologuard	2021-03-25
PMA P130017S047 Exact Sciences Corporation	Cologuard	2021-03-17
PMA P130017S045 Exact Sciences Corporation	Cologuard	2020-11-25
PMA P130017S044 Exact Sciences Corporation	Cologuard	2020-10-20
PMA P130017S043 Exact Sciences Corporation	Cologuard	2020-10-07
PMA P130017S042 Exact Sciences Corporation	Cologuard	2020-08-26
PMA P130017S041 Exact Sciences Corporation	Cologuard	2020-06-15
PMA P130017S040 Exact Sciences Corporation	Cologuard	2020-05-12
PMA P130017S039 Exact Sciences Corporation	Cologuard	2020-04-13
PMA P130017S038 Exact Sciences Corporation	Cologuard	2020-03-12
GUDID 00858637005383 EXACT SCIENCES CORPORATION	Cologuard Capture Wash Kit	2019-12-10
GUDID 00858637005376 EXACT SCIENCES CORPORATION	Cologuard Inhibitor Removal Tablet Kit	2019-12-10
GUDID 00858637005369 EXACT SCIENCES CORPORATION	Cologuard Binding Solution Kit	2019-12-10
GUDID 00858637005208 EXACT SCIENCES CORPORATION	Cologuard Spin Filter Kit	2019-12-10
GUDID 00858637005413 EXACT SCIENCES CORPORATION	STARlet Interface	2019-11-12
GUDID 00858637005406 EXACT SCIENCES CORPORATION	Analytical Client	2019-11-12
GUDID 00858637005390 EXACT SCIENCES CORPORATION	Analytical Server	2019-11-12
GUDID 00858637005352 EXACT SCIENCES CORPORATION	Cologuard Test Definition v1.4	2019-11-12
GUDID 00858637005321 EXACT SCIENCES CORPORATION	Cycler Control	2019-11-12
PMA P130017S035 Exact Sciences Corporation	COLOGUARD	2019-10-24
PMA P130017S036 Exact Sciences Corporation	Cologuard	2019-10-22
PMA P130017S034 Exact Sciences Corporation	Cologaurd	2019-10-08
PMA P130017S032 Exact Sciences Corporation	Cologuard	2019-09-06
GUDID 00858637005277 EXACT SCIENCES CORPORATION	Cologuard Test Definition v1.3	2019-07-31
PMA P130017S031 Exact Sciences Corporation	Cologuard	2019-06-13
PMA P130017S030 Exact Sciences Corporation	Cologuard Stool DNA-Based Colorectal Cancer Screening Test	2019-05-16
PMA P130017S028 Exact Sciences Corporation	Cologuard	2019-03-19
PMA P130017S026 Exact Sciences Corporation	COLOGUARD	2019-03-11
PMA P130017S025 Exact Sciences Corporation	Cologuard	2019-02-20
PMA P130017S024 Exact Sciences Corporation	Cologuard	2018-10-29
PMA P130017S023 Exact Sciences Corporation	Cologuard	2018-08-24
GUDID 00858637005314 EXACT SCIENCES CORPORATION	Cologuard Hemoglobin Bead Based Dilution Buffer Kit	2018-07-06
GUDID 00858637005307 EXACT SCIENCES CORPORATION	Cologuard Hemoglobin Bead Based Assay Wash	2018-07-06
GUDID 00858637005291 EXACT SCIENCES CORPORATION	Cologuard Hemoglobin Bead Based Assay Reagents Kit	2018-07-06
GUDID 00858637005284 EXACT SCIENCES CORPORATION	Cologuard Hemoglobin Bead Based Control Kit	2018-07-06
GUDID 00858637005253 EXACT SCIENCES CORPORATION	Home Page	2018-07-06
GUDID 00858637005246 EXACT SCIENCES CORPORATION	Reader Control	2018-07-06
GUDID 00858637005239 EXACT SCIENCES CORPORATION	STARlet Interface	2018-07-06
GUDID 00858637005222 EXACT SCIENCES CORPORATION	Analytical Server	2018-07-06
GUDID 00858637005215 EXACT SCIENCES CORPORATION	Analytical Client	2018-07-06
GUDID 00858637005185 EXACT SCIENCES CORPORATION	Cologuard Stool Buffer	2018-07-06
GUDID 00858637005178 EXACT SCIENCES CORPORATION	Cologuard Stool Buffer	2018-07-06
GUDID 00858637005161 EXACT SCIENCES CORPORATION	Cologuard Hemoglobin Assay Wash	2018-07-06
GUDID 00858637005154 EXACT SCIENCES CORPORATION	Cologuard Capture Bead Pre-Wash	2018-07-06
GUDID 00858637005147 EXACT SCIENCES CORPORATION	Cologuard Conversion Wash	2018-07-06
GUDID 00858637005130 EXACT SCIENCES CORPORATION	Cologuard Binding Solution	2018-07-06
GUDID 00858637005123 EXACT SCIENCES CORPORATION	Cologuard Capture Wash	2018-07-06
GUDID 00858637005116 EXACT SCIENCES CORPORATION	Cologuard Capture Solution	2018-07-06
GUDID 00858637005109 EXACT SCIENCES CORPORATION	Cologuard Spin Filter	2018-07-06
GUDID 00858637005093 EXACT SCIENCES CORPORATION	Cologuard Barcoded Mixing Tubes	2018-07-06
GUDID 00858637005086 EXACT SCIENCES CORPORATION	Cologuard Inhibitor Removal Tablet	2018-07-06
GUDID 00858637005079 EXACT SCIENCES CORPORATION	Cologuard DNA Control Kit	2018-07-06
GUDID 00858637005062 EXACT SCIENCES CORPORATION	Cologuard Hemoglobin Control Kit	2018-07-06
GUDID 00858637005055 EXACT SCIENCES CORPORATION	Cologuard Hemoglobin Assay Reagents	2018-07-06
GUDID 00858637005048 EXACT SCIENCES CORPORATION	Cologuard QuARTS Assay Reagents	2018-07-06
GUDID 00858637005031 EXACT SCIENCES CORPORATION	Cologuard DNA Preparation Reagent	2018-07-06
GUDID 00858637005017 EXACT SCIENCES CORPORATION	Cologuard Collection Kit	2018-07-06
GUDID 00858637005000 EXACT SCIENCES CORPORATION	Cologuard DNA Capture Reagents	2018-07-06
PMA P130017S022 Exact Sciences Corporation	Cologuard	2018-03-07
PMA P130017S021 Exact Sciences Corporation	Cologuard	2017-12-18
PMA P130017S017 Exact Sciences Corporation	Cologuard	2017-11-06
PMA P130017S020 Exact Sciences Corporation	Cologuard	2017-08-08
JQW Exact Sciences, Corporation [Exact Sciences Corp]	Capture Aspirator	2017-07-12
JQW Exact Sciences Corporation [Exact Sciences Corp]	Capture Aspirator	2017-07-12
JQW EXACT SCIENCES CORP	Capture Aspirator	2017-07-12
PMA P130017S018 Exact Sciences Corporation	Cologuard	2017-06-30
PMA P130017S019 Exact Sciences Corporation	Cologuard	2017-06-23
PMA P130017S015 Exact Sciences Corporation	Cologuard	2017-05-24
PMA P130017S016 Exact Sciences Corporation	COLOGUARD	2017-05-17
JTQ Exact Sciences, Corporation [Exact Sciences Corp]	Capture Incubator	2017-02-08
JTQ Exact Sciences, Corporation [Exact Sciences Corp]	Capture Incubator 2	2017-02-08
JTQ Exact Sciences Corporation [Exact Sciences Corp]	Capture Incubator	2017-02-08
JTQ Exact Sciences Corporation [Exact Sciences Corp]	Capture Incubator 2	2017-02-08
JTQ EXACT SCIENCES CORP	Capture Incubator	2017-02-08
JTQ EXACT SCIENCES CORP	Capture Incubator 2	2017-02-08
PMA P130017S014 Exact Sciences Corporation	COLOGUARD	2016-12-13
PMA P130017S013 Exact Sciences Corporation	COLOGUARD	2016-12-01
PMA P130017S012 Exact Sciences Corporation	COLOGUARD	2016-11-17
PMA P130017S010 Exact Sciences Corporation	COLOGUARD	2016-08-19
PMA P130017S011 Exact Sciences Corporation	COLOGUARD	2016-07-26
PMA P130017S009 Exact Sciences Corporation	COLOGUARD	2016-05-05
PMA P130017S008 Exact Sciences Corporation	COLOGUARD	2016-05-03
PMA P130017S007 Exact Sciences Corporation	COLOGUARD	2016-04-20
PMA P130017S006 Exact Sciences Corporation	COLOGUARD	2016-02-04
PMA P130017S005 Exact Sciences Corporation	COLOGUARD	2015-12-23
PMA P130017S004 Exact Sciences Corporation	COLOGUARD	2015-09-25
PMA P130017S003 Exact Sciences Corporation	COLOGUARD	2015-08-19
PMA P130017S002 Exact Sciences Corporation	COLOGUARD	2015-08-18
PMA P130017S001 Exact Sciences Corporation	COLOGUARD	2015-02-02
PMN P130017 | PHP Exact Sciences Corporation [Exact Sciences Corp]	Cologuard	2014-08-18
PMN P130017 | PHP EXACT SCIENCES CORP	Cologuard	2014-08-18
JRO Exact Sciences, Corporation [Exact Sciences Corp]	Sample Mixer	2014-08-18
JRO Exact Sciences, Corporation [Exact Sciences Corp]	Sample Mixer 2	2014-08-18
JRO Exact Sciences Corporation [Exact Sciences Corp]	Sample Mixer	2014-08-18
JRO Exact Sciences Corporation [Exact Sciences Corp]	Sample Mixer 2	2014-08-18
JRO EXACT SCIENCES CORP	Sample Mixer	2014-08-18
JRO EXACT SCIENCES CORP	Sample Mixer 2	2014-08-18
PMA P130017 Exact Sciences Corporation	COLOGUARD	2014-08-11

Similar & Related FDA Registered Companies

• Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS054 Date Received07/11/2022 Decision Date08/03/2022 Product Code PHP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS053 Date Received06/21/2022 Decision Date07/19/2022 Product Code PHP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS052 Date Received06/08/2022 Decision Date07/07/2022 Product Code PHP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS051 Date Received03/02/2022 Decision Date04/13/2022 Product Code PHP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	616A5	EXACT SCIENCES CORPORATION
CAGE Code	616A5	EXACT SCIENCES CORPORATION
CAGE Code	77SU0	EXACT SCIENCES CORPORATION EXACT SCIENCES LABORATORIES, LLC
S.A.M. Registration	77SU0 [150908853]	EXACT SCIENCES CORPORATION
S.A.M. Registration	77SU0 [150908853]	EXACT SCIENCES CORPORATION
DUNS	150908853	Exact Sciences Corporation
DUNS	157451142	EXACT SCIENCES CORPORATION
SEC	0001124140	EXACT SCIENCES CORP of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019121239592	Anvers,Belgium -> New York, New York	RETURN SHIPMENT OF UNUED SAMPLE MATERIALS, NO. PR-2614821 (COLLLI NO. 1-11 / 11) BOTTLES AND CAPS HS CODES: 392330, 392350	9 PKG
2019072622769	Anvers,Belgium -> Baltimore, Maryland	FILLING & CLOSING MACHINE SERIAL NO.: 4039200 WITH ACCESSORIES HS-CODE: 842230	3 PKG
2018050861453	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	PLASTIC PROFILES	100 PKG