GlucoLin

GUDID 08718734961406

GlucoLin is an assayed glucose control intended for professional use in the verification of the linearity of the HemoCue® Glucose systems. 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

Eurotrol B.V.

Glucose IVD, control

• Primary Device ID: 08718734961406
• NIH Device Record Key: 33d067a9-b8f9-4eff-8caa-30fcce4f9d4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlucoLin
• Version Model Number: 025.000.005
• Company DUNS: 412925992
• Company Name: Eurotrol B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08718734961406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963909

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-16
• Device Publish Date: 2020-10-08

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