Assure® Dose High (Level 2) Control Solution

GUDID 00015482500061

Assure Dose Normal (Level 1), High (Level 2) 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. (Primary UPC# 015482500061 is used as the assigned UDI for the Class I device.)

ARKRAY USA, INC.

Glucose IVD, control

• Primary Device ID: 00015482500061
• NIH Device Record Key: 1bef3c1d-d84d-458d-a80f-5ff26a9b63b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® Dose High (Level 2) Control Solution
• Version Model Number: 500006
• 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: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482500061 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-08-06
• Device Publish Date: 2019-01-15

On-Brand Devices [Assure® Dose High (Level 2) Control Solution]

• 00015482502058: Assure® Dose High (Level 2) Control Solution contains a known amount of glucose that reacts wit
• 00015482500061: Assure Dose Normal (Level 1), High (Level 2) Control Solution contains a known amount of glucose