AccessGUDID - DEVICE: CoaguChek XS Patient Self Testing Care Kit (04015630945689)

GUDID

Device Identifier (DI) Information

Brand Name: CoaguChek XS Patient Self Testing Care Kit
Version or Model: 03666794001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03666794001
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630945689
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *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?
56887	Cancer antigen 15-3 (CA15-3) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GJS	Test, Time, Prothrombin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062925	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
Storage Environment Temperature: between 1 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 251487ff-9776-4511-a45f-de28ec6873c2
Public Version Date: November 10, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016