Vigil 650038

GUDID 15099590232108

Vigil HbA1c Controls Levels 1 & 2

Beckman Coulter, Inc.

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 15099590232108
• NIH Device Record Key: 29b2e3b0-49c8-4784-91fe-626176c5a2af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vigil
• Version Model Number: 650038
• Catalog Number: 650038
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	15099590232108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982022

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

On-Brand Devices [Vigil]

• 15099590232108: Vigil HbA1c Controls Levels 1 & 2
• 15099590227357: Vigil Serology Control Level 2
• 15099590227333: Vigil Serology Control Level 3
• 15099590227326: Vigil Serology Control Level C
• 15099590226916: Vigil Protein Control Level 1
• 15099590225421: Vigil TDM Control level 2
• 15099590225414: Vigil TDM Control level 3
• 15099590225315: Vigil TDM Control level 1
• 15099590223045: Vigil Protein Control Level 2
• 15099590222925: Vigil Lipid Control Level 2
• 15099590222918: Vigil Lipid Control Level 3
• 15099590222901: Vigil Lipid Control Level 4
• 15099590222611: Vigil Protein Control Level 3
• 15099590222604: Vigil Serology Control Level 1
• 15099590221270: Vigil Lipid Control Level 1