CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691

Basic Information

• Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691
• Primary DI: 00817302020069
• Version / Model: CC691
• Catalog Number: CC691
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: 4ad9451a-b8c3-4536-832f-ec436ece12ba

Device Description

CYST (Cystatin-C) 2 x 100 tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDY	TEST, CYSTATIN C	Clinical Chemistry	862.1225	2
JIT	CALIBRATOR, SECONDARY	Clinical Chemistry	862.1150	2
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302020069	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Unopened reagents are stable to expiration date with stored at 2 to 8°C
• Type: Special Storage Condition, Specify
• Special Conditions: Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius