Alere Afinion HbA1c Control 1115178

GUDID 07070060006505

HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 Control C1. 1 Control C II. 1 package insert. DI covers Alere Afinion HbA1c Control and Afinion HbA1c Control.

Abbott Diagnostics Technologies AS

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 07070060006505
• NIH Device Record Key: 5c7ffd08-2451-4cf4-9530-2d72dcae95a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Afinion HbA1c Control
• Version Model Number: 1115178
• Catalog Number: 1115178
• Company DUNS: 515324122
• Company Name: Abbott Diagnostics Technologies AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07070060006505 [Primary]

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: 2019-05-09
• Device Publish Date: 2018-05-07

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