AU

GUDID 15099590012120

HbA1c Advanced

BECKMAN COULTER IRELAND INC.

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 15099590012120
• NIH Device Record Key: b0cf24b8-d07d-49a8-9da8-5ab20d106480
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AU
• Version Model Number: B93009
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 to 8 degrees celcius
• Special Storage Condition, Specify: Between 0 and 0 *Store at 2 to 8 degrees celcius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590012120 [Primary]

FDA Product Code

• PDJ: Hemoglobin A1c Test System

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: 2019-03-11
• Device Publish Date: 2019-02-13

On-Brand Devices [AU ]

• 15099590666361: Urine CSF Albumin Calibrator
• 15099590635602: Lyophilized Chemistry Calibrator Level 1
• 15099590635572: Lyophilized Chemistry Calibrator Level 2
• 15099590131180: SYSTEM CALIBRATOR
• 15099590070441: BICARBONATE CALIBRATOR
• 15099590012120: HbA1c Advanced
• 15099590010645: MICROALBUMIN
• 15099590010607: α-1 ANTITRYPSIN
• 15099590010591: α-1 Acidglycoprotein