Eurotrol GlucoTrol-AQ

GUDID 08718734960935

Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer. A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material: GlucoTrol-AQ Low (1): 08718734961536 GlucoTrol-AQ High (3): 08718734961543

Eurotrol B.V.

Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control

• Primary Device ID: 08718734960935
• NIH Device Record Key: 8c9ddf68-0ae4-437d-9bc5-326789db7cd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eurotrol GlucoTrol-AQ
• Version Model Number: 180.013.002
• 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	08718734960935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964053

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

Devices Manufactured by Eurotrol B.V.

• 08718734960867 - Eurotrol: 2022-09-16
• 08718734960881 - Eurotrol: 2022-09-16
• 08718734960904 - Eurotrol: 2022-09-16
• 08718734960928 - Eurotrol: 2022-09-16 Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level. It is a convenience kit for the purposes
• 08718734961000 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX S1A is an assayed quality control material for professional use to verify the performance characteristics of the
• 08718734961062 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX S3A is an assayed quality control material for professional use to verify the performance characteristics of the
• 08718734961079 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX S5A is an assayed quality control material for professional use to verify the performance characteristics of the
• 08718734961086 - CueSee® CO-OX: 2021-12-27 CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the performance characteristics of the