AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 (00817302020106)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052
Version or Model: CC052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC052
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: HCY (Homocysteine) Level 2 control 6 x 5 mL

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:	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?
53750	Homocysteine IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
LPS	URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM

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
Special Storage Condition, Specify: Controls are stable if refrigerated (2 to 8 °) until the date of expiration
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter
Device Size Text, specify: Kit contains 6 control bottles and 1 package insert

Device Record Status

Public Device Record Key: b3ad2757-83ab-4516-beb0-d8d7aeae82eb
Public Version Date: August 20, 2024
Public Version Number: 3
DI Record Publish Date: September 01, 2016