GlucoLin

Basic Information

• Brand Name: GlucoLin
• Primary DI: 08718734961406
• Version / Model: 025.000.005
• Company Name: Eurotrol B.V.
• Labeler DUNS: 412925992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-08
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 33d067a9-b8f9-4eff-8caa-30fcce4f9d4f

Device Description

GlucoLin is an assayed quality control material for professional use to verify the performance characteristics of HemoCue® Glucose systems. Glucolin is intended for the quantitative determination of glucose. A box of GlucoLin contains 5 levels of control material: GlucoLin XLow: 08718734961352 GlucoLin Low: 08718734961369 GlucoLin Normal: 08718734961376 GlucoLin High: 08718734961383 GlucoLin XHigh: 08718734961390

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718734961406	GS1

Premarket Submissions

Submission Number	Supplement Number
K963909	000