AccessGUDID - DEVICE: CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) (05055273216899)

GUDID

Device Identifier (DI) Information

Brand Name: CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2)
Version or Model: CYS10446
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CYS10446
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273216899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: Intended for in vitro diagnostic (IVD) use in quality control of Randox Cystatin C assay. For use in a clinical laboratory setting by trained personnel.

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:	Yes
Prescription Use (Rx):	Yes
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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6eaf1f48-f068-468c-b616-2a22018f71a9
Public Version Date: February 17, 2022
Public Version Number: 1
DI Record Publish Date: February 09, 2022