Well at Walgreens - The Walgreens At-Home A1C Test Kit provides - WALGREEN CO.

Duns Number:008965063

Device Description: The Walgreens At-Home A1C Test Kit provides quantitative measurement of the percent of gly 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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More Product Details

Catalog Number

3056

Brand Name

Well at Walgreens

Version/Model Number

3056

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090413,K090413

Product Code Details

Product Code

LCP

Product Code Name

Assay, Glycosylated Hemoglobin

Device Record Status

Public Device Record Key

3242203b-2f5f-44f8-9f72-9b996a1d7937

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WALGREEN CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75
2 A medical device with a moderate to high risk that requires special controls. 74
U Unclassified 2