FDA.reportPublic FDA data

CVS Health At Home A1C Test Kit

Primary DI
00050428350423
Brand
CVS Health At Home A1C Test Kit
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
3059
Catalog number
3059
Device description
The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Published
2016-11-15
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
00050428350423PrimaryGS10
10050428350420Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428350423000504283504230504283504230050428350423
1005042835042010050428350420

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, Specify00Do not use if dot is red or if the product is past the expiration date.
Special Storage Condition, Specify00Store out of direct sunlight.
Special Storage Condition, Specify00Use indoors at room temperature.
Storage Environment Temperature64 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-746-7287xx@xx.xx

Regulatory Flags#

DUNS number
062312574
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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00860004423492QvinQurasense, Inc.LCP2026-05-08
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04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONLCP2026-01-05
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