GLYCOMARK

Basic Information

• Brand Name: GLYCOMARK
• Primary DI: 04987170775562
• Version / Model: NK-8300
• Company Name: NIPPON KAYAKU CO., LTD.
• Labeler DUNS: 690547468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2020-12-22
• Public Version Status: Update
• Public Device Record Key: 64f99906-056f-4973-a337-65cc34314faf

Device Description

Kit Reagents 1,5-anhydroglucitol (1,5-AG) Enzymatic 1,5-AG Assay for Glycemic Control

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
NOZ	Assay, 1,5-Anhydroglucitol (15ag)	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53214	1,5-Anhydroglucitol IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of 1,5-anhydroglucitol in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987170775562	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10 Milliliter (Reagent 2)
Device Size Text, specify			20 Milliliter (Reagent 1)

Storage Conditions

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