Exact Sciences Corporation

FDA Filings

This page includes the latest FDA filings for Exact Sciences Corporation. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
Exact Sciences Corporation
Cologuard2020-03-12
Exact Sciences Corporation
COLOGUARD2019-10-24
Exact Sciences Corporation
Cologuard2019-10-22
Exact Sciences Corporation
Cologaurd2019-10-08
Exact Sciences Corporation
Cologuard2019-09-06
Exact Sciences Corporation
Cologuard2019-06-13
Exact Sciences Corporation
Cologuard Stool DNA-Based Colorectal Cancer Screening Test2019-05-16
Exact Sciences Corporation
Cologuard2019-03-19
Exact Sciences Corporation
COLOGUARD2019-03-11
Exact Sciences Corporation
Cologuard2019-02-20
Exact Sciences Corporation
Cologuard2018-10-29
Exact Sciences Corporation
Cologuard2018-08-24
Exact Sciences Corporation
Cologuard2018-03-07
Exact Sciences Corporation
Cologuard2017-12-18
Exact Sciences Corporation
Cologuard2017-11-06
Exact Sciences Corporation
Cologuard2017-08-08
Exact Sciences Corporation
Cologuard2017-06-30
Exact Sciences Corporation
Cologuard2017-06-23
Exact Sciences Corporation
Cologuard2017-05-24
Exact Sciences Corporation
COLOGUARD2017-05-17
Exact Sciences Corporation
COLOGUARD2016-12-13
Exact Sciences Corporation
COLOGUARD2016-12-01
Exact Sciences Corporation
COLOGUARD2016-11-17
Exact Sciences Corporation
COLOGUARD2016-08-19
Exact Sciences Corporation
COLOGUARD2016-07-26
Exact Sciences Corporation
COLOGUARD2016-05-05
Exact Sciences Corporation
COLOGUARD2016-05-03
Exact Sciences Corporation
COLOGUARD2016-04-20
Exact Sciences Corporation
COLOGUARD2016-02-04
Exact Sciences Corporation
COLOGUARD2015-12-23

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Cologuard Capture Wash Kit
EXACT SCIENCES CORPORATION2019-12-10
Cologuard Inhibitor Removal Tablet Kit
EXACT SCIENCES CORPORATION2019-12-10
Cologuard Binding Solution Kit
EXACT SCIENCES CORPORATION2019-12-10
Cologuard Spin Filter Kit
EXACT SCIENCES CORPORATION2019-12-10
STARlet Interface
EXACT SCIENCES CORPORATION2019-11-12
Analytical Client
EXACT SCIENCES CORPORATION2019-11-12
Analytical Server
EXACT SCIENCES CORPORATION2019-11-12
Cologuard Test Definition v1.4
EXACT SCIENCES CORPORATION2019-11-12
Cycler Control
EXACT SCIENCES CORPORATION2019-11-12
Cologuard Hemoglobin Bead Based Dilution Buffer Ki
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Hemoglobin Bead Based Assay Wash
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Hemoglobin Bead Based Assay Reagents Kit
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Hemoglobin Bead Based Control Kit
EXACT SCIENCES CORPORATION2018-07-06
Home Page
EXACT SCIENCES CORPORATION2018-07-06
Reader Control
EXACT SCIENCES CORPORATION2018-07-06
STARlet Interface
EXACT SCIENCES CORPORATION2018-07-06
Analytical Server
EXACT SCIENCES CORPORATION2018-07-06
Analytical Client
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Stool Buffer
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Stool Buffer
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Hemoglobin Assay Wash
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Capture Bead Pre-Wash
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Conversion Wash
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Binding Solution
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Capture Wash
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Capture Solution
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Spin Filter
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Barcoded Mixing Tubes
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Inhibitor Removal Tablet
EXACT SCIENCES CORPORATION2018-07-06
Cologuard DNA Control Kit
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Hemoglobin Control Kit
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Hemoglobin Assay Reagents
EXACT SCIENCES CORPORATION2018-07-06
Cologuard QuARTS Assay Reagents
EXACT SCIENCES CORPORATION2018-07-06
Cologuard DNA Preparation Reagent
EXACT SCIENCES CORPORATION2018-07-06
Cologuard Collection Kit
EXACT SCIENCES CORPORATION2018-07-06

Related Finance Registrations
EXACT SCIENCES CORP of DELAWARE0001124140
Legal Entity Identifier 549300VM3X1FYD4N9Z14 [Exact Sciences Corporation]
D.U.N.S. 150908853 [Exact Sciences Corporation]
D.U.N.S. 157451142 [EXACT SCIENCES CORPORATION]

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