Assure® Dose Normal (Level 1) Control Solution

GUDID 00015482502041

Assure® Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with logbook and CS insert.)

ARKRAY USA, INC.

Glucose IVD, control

• Primary Device ID: 00015482502041
• NIH Device Record Key: e0900ba0-abd9-4eab-8808-064a759836b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® Dose Normal (Level 1) Control Solution
• Version Model Number: 502004
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482502041 [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: 2020-03-09
• Device Publish Date: 2020-02-28

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