AccessGUDID - DEVICE: Cologuard Hemoglobin Assay Reagents (00858637005055)

GUDID

Device Identifier (DI) Information

Brand Name: Cologuard Hemoglobin Assay Reagents
Version or Model: 100031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EXACT SCIENCES CORPORATION

Primary DI Number: 00858637005055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 150908853 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54533	Faecal occult blood IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130017	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2801c7e-7983-4fc8-bd40-f9117941f859
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 17, 2014