Afinion HbA1c 1116974

GUDID 07070060014654

Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 test cartridges, 1 package insert

Abbott Diagnostics Technologies AS

Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 07070060014654
• NIH Device Record Key: e0c52daf-24e7-4318-ad9b-477856bb8b69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Afinion HbA1c
• Version Model Number: 1116974
• Catalog Number: 1116974
• 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: false
• 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

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
• 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	07070060014654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171650

FDA Product Code

• JFY: Enzymatic Method, Creatinine

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: 2019-05-24
• Device Publish Date: 2019-05-16

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