Cologuard Hemoglobin Control Kit

GUDID 00858637005062

EXACT SCIENCES CORPORATION

Faecal occult blood IVD, control
Primary Device ID00858637005062
NIH Device Record Key91423afb-10d6-4106-94ab-2f0ccaca5b75
Commercial Distribution StatusIn Commercial Distribution
Brand NameCologuard Hemoglobin Control Kit
Version Model Number100073
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858637005062 [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

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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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