Aution™ AU Control Solution

GUDID 04987486738060

Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality co

ARKRAY USA, INC.

Multiple urine analyte IVD, control

• Primary Device ID: 04987486738060
• NIH Device Record Key: 6cb96b1a-b9f6-429b-bebc-ebcada002a0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aution™ AU Control Solution
• Version Model Number: 73806
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-855-646-3108
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486738060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121456

FDA Product Code

• JJW: Urinalysis 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: 2018-10-26
• Device Publish Date: 2018-09-25

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