Eurotrol AlbuTrol 189.002.002

GUDID 08718734960638

Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin.

Eurotrol B.V.

Albumin IVD, control

• Primary Device ID: 08718734960638
• NIH Device Record Key: 697bb490-77fd-4985-8bc8-34cb1f0b7647
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eurotrol AlbuTrol
• Version Model Number: AlbuTrol Level 2
• Catalog Number: 189.002.002
• 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	08718734960638 [Package]; Contains: 08718734960645; Package: Product Box [2 Units]; In Commercial Distribution
GS1	08718734960645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060215

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

On-Brand Devices [Eurotrol AlbuTrol]

• 08718734960638: Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verificat
• 08718734960614: Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verificat