AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692 (00817302022940)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692
Version or Model: CC692
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC692
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022940
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CKMB 2 x 60 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?
52996	Creatine kinase myocardial isoenzyme (CKMB) 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 creatine kinase myocardial isoenzyme (CKMB) 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: After reconstitution, the reagent is stable for 5 days when stored at 2-8°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: 15 Milliliter
Device Size Text, specify: Kit contains 2 empty reagent cartridges, 2 CKMB Reagent bottles, 1 package insert and 1 user defined parameter

Device Record Status

Public Device Record Key: 474ff86a-bf1e-403e-b49f-992dcc45fc93
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 12, 2016