AUTION Check Plus Controls

GUDID 04987486009801

Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.)

ARKRAY USA, INC.

Multiple urine analyte IVD, control

• Primary Device ID: 04987486009801
• NIH Device Record Key: 6718536b-dae0-47e5-9449-304ad15e4f08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTION Check Plus Controls
• Version Model Number: 102478
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987486009801 [Primary]

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: 2020-03-05
• Device Publish Date: 2020-02-26

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