DEVICE: Well at Walgreens (00311917169835)

Device Identifier (DI) Information

Well at Walgreens
3056
In Commercial Distribution
3056
WALGREEN CO.
00311917169835
GS1

2
008965063 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Glycated haemoglobin (HbA1c) monitoring system IVD, home-use A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.
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FDA Product Code

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Product Code Product Code Name
LCP Assay, Glycosylated Hemoglobin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090413 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 18 and 25 Degrees Celsius
Special Storage Condition, Specify: Avoid running test on hot or cold surfaces or near sources of hot or cold.
Special Storage Condition, Specify: 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: 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: Do not use if dot is red or if the product is past the expiration date.
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3242203b-2f5f-44f8-9f72-9b996a1d7937
July 06, 2018
3
August 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 10311917169832 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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1-800-925-4733
consumerrelations.pq@walgreens.com
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