Cologuard 2 Test Definition

GUDID 00858637005901

EXACT SCIENCES CORPORATION

Laboratory instrument/analyser application software IVD
Primary Device ID00858637005901
NIH Device Record Keyb13ede65-1a88-4101-bf47-d59c8e16698c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCologuard 2 Test Definition
Version Model Number1.1
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858637005901 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-27
Device Publish Date2025-03-19

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
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)

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