FDA.reportPublic FDA data

ReliOn® Prime Blood Glucose Test Strips

Primary DI
00605388022943
Brand
ReliOn® Prime Blood Glucose Test Strips
Company
WAL-MART STORES, INC.
Model
700050 / 700100
Device description
Blood Glucose Test Strips
Published
2017-02-17
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
CGAGLUCOSE OXIDASE, GLUCOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091102000ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSArkray Factory USA, Inc.2009-10-23CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681131078221PackageGS12
10605388022940PackageGS112In Commercial Distribution
10681131078228PackageGS16
00605388022943PrimaryGS10
50605388022948Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681131078221006811310782216811310782210681131078221
1060538802294010605388022940
1068113107822810681131078228
00605388022943006053880229436053880229430605388022943
5060538802294850605388022948

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature39 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(855)776-0662xxx@xxx.xxx

Regulatory Flags#

DUNS number
051957769
Device count
50
Lot or batch
true
Expiration date on label
true

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06979191882242Nanacarewhite2026-07-31
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06979191882280Nanacare69791918822802026-07-31
06979191883690EQUATEwhite2026-07-31
06979191883706EQUATEblue2026-07-31
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Primary DI, Brand, Company table
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04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
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