K-ASSAY® Cystatin C Reagent (L)

Basic Information

• Brand Name: K-ASSAY® Cystatin C Reagent (L)
• Primary DI: 00816426020320
• Version / Model: KAI-074
• Catalog Number: KAI-074
• Company Name: KAMIYA BIOMEDICAL COMPANY, LLC
• Labeler DUNS: 197934250
• 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: 61f1e051-e639-4063-9674-b010c3f9939d

Device Description

For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay.

Device Characteristics

• Single Use: No
• 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	00816426020320	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093137	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius