AccessGUDID - DEVICE: Gentian Cystatin C Control Kit (2 x 5mL) (07090038460085)

GUDID

Device Identifier (DI) Information

Brand Name: Gentian Cystatin C Control Kit (2 x 5mL)
Version or Model: 1026
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gentian AS

Primary DI Number: 07090038460085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 730958121 *Terms of Use

Device Description: The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay.

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?
48175	Cystatin C IVD, control	A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDY	Test, Cystatin C

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071388	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: 7de11c67-8e17-4703-8ec4-4554bfb52dbd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 24, 2016