AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.™ CK CREATINE KINASE REAGENT CC207 (00817302020519)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.™ CK CREATINE KINASE REAGENT CC207
Version or Model: CC207
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC207
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CK (Creatine Kinase) 2 x 200 tests

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:	Yes
Combination Product:	Yes
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?
52989	Creatine kinase (CK) multiple isoenzyme IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGS	NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES

FDA Premarket Submission

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

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 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, Specify: Reagent is stable when stored at 2-8° C until expiration date

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 60 Milliliter
Total Volume: 10 Milliliter
Device Size Text, specify: Kit contains 2 reagent cartridges and 1 package insert

Device Record Status

Public Device Record Key: 0a7a2343-5e48-4769-802a-0dbbe871d104
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016