Home Page

GUDID 00858637005253

EXACT SCIENCES CORPORATION

Laboratory instrument application software IVD
Primary Device ID00858637005253
NIH Device Record Key51717a1e-4954-4e6b-885d-4ec39f55d57f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHome Page
Version Model Number2.0
Company DUNS150908853
Company NameEXACT SCIENCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858637005253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-21

Devices Manufactured by EXACT SCIENCES CORPORATION

00858637005840 - Analysis Server v2.22025-03-27 Exact Sciences Software System 2.2
00858637005857 - Analysis Client v2.22025-03-27 Exact Sciences Software System 2.2
00858637005864 - STARlet Interface v2.22025-03-27 Exact Sciences Software System 2.2
00858637005871 - Cycler Control v2.22025-03-27 Exact Sciences Software System 2.2
00858637005888 - Cologuard Test Definition v1.72025-03-27
00858637005901 - Cologuard 2 Test Definition2025-03-27
00858637005949 - The Cologuard Plus Collection Kit2025-03-27
00850057859003 - CG2 CAP BDS2025-02-27 Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea)

Trademark Results [Home Page]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HOME PAGE
HOME PAGE
79096539 4235690 Dead/Cancelled
HangZhou RunDong Garments Co., Ltd
2011-04-05
HOME PAGE
HOME PAGE
75085302 not registered Dead/Abandoned
EPR Investments, Inc.
1996-04-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.