Well at Walgreens

Primary DI
00311917169835
Brand
Well at Walgreens
Company
WALGREEN CO.
Model
3056
Catalog number
3056
Device description
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.
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090413000A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECBayer Healthcare, LLC2009-05-14LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10038193303018PackageGS124In Commercial Distribution
00311917169835PrimaryGS10
10311917169832Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003819330301810038193303018
00311917169835003119171698353119171698350311917169835
1031191716983210311917169832

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) monitoring system IVD, home-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid running test on hot or cold surfaces or near sources of hot or cold.
Special Storage Condition, Specify00Do not use if dot is red or if the product is past the expiration date.
Special Storage Condition, Specify00If 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, Specify00Use 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).
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature64 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-925-4733consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

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00311917065762WALGREENS8416972025-04-29
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00311917199603WALGREENS8281472022-03-25

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