Gentian Cystatin C Calibrator

Basic Information

• Brand Name: Gentian Cystatin C Calibrator
• Primary DI: 07090038460092
• Version / Model: 1012
• Company Name: Gentian AS
• Labeler DUNS: 730958121
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fd3b0d19-fa80-440c-ad65-be6814e5a73a

Device Description

The Gentian Cystatin C Calibrator is intended to be used to establish a calibration curve for measuring Cystatin C concentration in human serum or plasma with the Gentian Cystatin C Immunoassay.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
48174	Cystatin C IVD, calibrator	A material which is used to establish known points of reference for an assay that is intended to be 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	07090038460092	GS1

Premarket Submissions

Submission Number	Supplement Number
K071388	000