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

• 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

Devices Manufactured by Abbott Diagnostics Technologies AS

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