AccessGUDID - DEVICE: Cologuard Binding Solution Kit (00858637005369)

GUDID

Device Identifier (DI) Information

Brand Name: Cologuard Binding Solution Kit
Version or Model: 100284
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EXACT SCIENCES CORPORATION

Primary DI Number: 00858637005369
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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	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: 2a2632ee-ed03-4ea7-a882-1ec8533c0491
Public Version Date: December 10, 2019
Public Version Number: 1
DI Record Publish Date: December 02, 2019