Cologuard Hemoglobin Bead Based Assay Wash

GUDID 00858637005307

EXACT SCIENCES CORPORATION

Faecal occult blood IVD, reagent
Primary Device ID00858637005307
NIH Device Record Keya70f9c2b-9baf-4587-a6d3-da8fb4a8a7e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCologuard Hemoglobin Bead Based Assay Wash
Version Model Number100205
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 Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858637005307 [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 Date2017-12-01

Devices Manufactured by EXACT SCIENCES CORPORATION

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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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