AccessGUDID - DEVICE: CK-MB CAL (05055273201451)

GUDID

Device Identifier (DI) Information

Brand Name: CK-MB CAL
Version or Model: CK2393
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CK2393
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273201451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The device is intended for use in the calibration of CK-MB assays in clinical chemistry systems.

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?
44694	Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	Calibrator, Secondary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123977	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
Special Storage Condition, Specify: Once reconstituted CK-MB is stable in the serum for 5 days at +4°C, 8 hours at +25°C and 4 weeks at –20°C when frozen once.
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: 76b4cd3a-c7bc-43c2-a624-f8638bf22a8f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016