AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691 (00817302020069)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691
Version or Model: CC691
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC691
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CYST (Cystatin-C) 2 x 100 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?
58914	Cystatin C IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDY	TEST, CYSTATIN C
JIT	CALIBRATOR, SECONDARY
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: 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: Unopened reagents are stable to expiration date with stored at 2 to 8°C
Special Storage Condition, Specify: Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4.5 Milliliter
Total Volume: 20 Milliliter
Device Size Text, specify: Kit contains 2 cartridges which contain R1 and R2 and 1 package insert

Device Record Status

Public Device Record Key: 4ad9451a-b8c3-4536-832f-ec436ece12ba
Public Version Date: August 14, 2023
Public Version Number: 3
DI Record Publish Date: September 01, 2016