Afinion ACR 1116972

GUDID 07070060014630

Albumin/Creatinine ration test kit. Intended use: For the determination of albumin, creatinine and albumin/creatinine ration in human urine. Contetns: 15 test cartridges. 1 package insert.

Abbott Diagnostics Technologies AS

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• Primary Device ID: 07070060014630
• NIH Device Record Key: d3e50eb5-2f47-4e28-b247-513e701f9b11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Afinion ACR
• Version Model Number: 1116972
• Catalog Number: 1116972
• 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	07070060014630 [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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