Cologuard Stool Buffer

GUDID 00858637005178

EXACT SCIENCES CORPORATION

Nucleic acid extraction/isolation kit IVD
Primary Device ID00858637005178
NIH Device Record Key3aef2328-7e39-43fc-9614-ecadd56fbd27
Commercial Distribution StatusIn Commercial Distribution
Brand NameCologuard Stool Buffer
Version Model Number200204
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
GS100858637005178 [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 Date2015-02-11

On-Brand Devices [Cologuard Stool Buffer]

00858637005185200204
00858637005178200204

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