CVS Health At Home A1C Test Kit 3059

GUDID 00050428350423

The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blo

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
Primary Device ID00050428350423
NIH Device Record Keyb7a5cef9-a8b1-44c6-836d-ba61ed241390
Commercial Distribution StatusIn Commercial Distribution
Brand NameCVS Health At Home A1C Test Kit
Version Model Number3059
Catalog Number3059
Company DUNS062312574
Company NameWOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-746-7287
Emailxx@xx.xx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Use indoors at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if dot is red or if the product is past the expiration date.
Special Storage Condition, SpecifyBetween 0 and 0 *Store out of direct sunlight.
Storage Environment TemperatureBetween 64 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100050428350423 [Primary]
GS110050428350420 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCPAssay, Glycosylated Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-15

On-Brand Devices [CVS Health At Home A1C Test Kit]

00050428526859The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated
00050428350423The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated

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