Well at Walgreens 3056

GUDID 00311917169835

The Walgreens At-Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.

WALGREEN CO.

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use

• Primary Device ID: 00311917169835
• NIH Device Record Key: 3242203b-2f5f-44f8-9f72-9b996a1d7937
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well at Walgreens
• Version Model Number: 3056
• Catalog Number: 3056
• Company DUNS: 008965063
• Company Name: WALGREEN CO.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com
• Phone: 1-800-925-4733
• Email: consumerrelations.pq@walgreens.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid running test on hot or cold surfaces or near sources of hot or cold.
• Special Storage Condition, Specify: Between 0 and 0 *If test has recently been at temperatures above 77 degrees F / 25 C, or below 64 F / 18 C, allow all kit parts to come to room temperature (64-77 F / 18 -25 C) for at least one hour before testing.
• Special Storage Condition, Specify: Between 0 and 0 *Use at room temperature and out of direct sunlight. If you cannot confidently store the kit under these recommended conditions, you have the option of refrigerating the kit (do not freeze).
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00311917169835 [Primary]
GS1	10038193303018 [Package]; Package: Case Pack [24 Units]; In Commercial Distribution
GS1	10311917169832 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090413

FDA Product Code

• LCP: Assay, Glycosylated Hemoglobin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-15

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