Alere Afinion™ HbA1c 1115015

GUDID 07070060005683

Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 Test Cartridges. 1 Package Insert. DI covers Alere Afinion HbA1c and Afinion HbA1c.

Abbott Diagnostics Technologies AS

Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 07070060005683
• NIH Device Record Key: 58257f34-bebd-435b-bc72-05f746d12c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Afinion™ HbA1c
• Version Model Number: 1115015
• Catalog Number: 1115015
• Company DUNS: 515324122
• Company Name: Abbott Diagnostics Technologies AS
• 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

Customer Support Contacts

• Phone: 1-866-216-9505
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07070060005683 [Primary]

FDA Product Code

• LCP: Assay, Glycosylated Hemoglobin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-09
• Device Publish Date: 2016-09-16

Devices Manufactured by Abbott Diagnostics Technologies AS

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