CYSC

Basic Information

• Brand Name: CYSC
• Primary DI: 05055273208665
• Version / Model: CYS4004
• Catalog Number: CYS4004
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1416760a-7479-4cf0-8984-5037e0308664

Device Description

The device is intended for the quantitative in vitro determination of Cystatin C in serum or plasma.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
48177	Cystatin C IVD, reagent	A reagent which is 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 cystatin C protein in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273208665	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083906	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Reagents are stable for 28 days on board the analyzer at approximately +10°C.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius