Cologuard Hemoglobin Assay Wash

GUDID 00858637005161

EXACT SCIENCES CORPORATION

Faecal occult blood IVD, reagent
Primary Device ID00858637005161
NIH Device Record Keya5e0871e-a6b2-486a-9ab7-7a99e2ae4467
Commercial Distribution StatusIn Commercial Distribution
Brand NameCologuard Hemoglobin Assay Wash
Version Model Number100111
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858637005161 [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 Date2014-11-17

Devices Manufactured by EXACT SCIENCES CORPORATION

00858637005833 - Reader Control v2.22024-05-03 Reader Control v2.2 for Exact Sciences System Software
00858637005338 - Cologuard STL BFR2024-02-02 Stool Buffer, 1000 L
00858637005932 - Cologuard FILT2024-02-02 Spin Filter, 300 ea
00858637005420 - D CTRL 1 Kit2021-09-06
00858637005437 - D CTRL 2 Kit2021-09-06
00858637005444 - D CTRL 3 Kit2021-09-06
00858637005451 - D CAL 1 Kit2021-09-06
00858637005468 - D CAL 2 Kit2021-09-06

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