Afinion HbA1c Calibration Verification

GUDID 07070060015798

HbA1c Calibration Verification for use with the Afinion™ HbA1c test. Content: 1 Control C I. 1 Control C II. 1 package insert

Abbott Diagnostics Technologies AS

Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 07070060015798
• NIH Device Record Key: 33606cea-9fa6-4823-930f-7104e83059b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Afinion HbA1c Calibration Verification
• Version Model Number: 1116792
• 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: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07070060015798 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-29
• Device Publish Date: 2024-03-21

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• 07070060015798 - Afinion HbA1c Calibration Verification: 2024-03-29 HbA1c Calibration Verification for use with the Afinion™ HbA1c test. Content: 1 Control C I. 1 Control C II. 1 package insert
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