FDA.reportPublic FDA data

GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS

Primary DI
00015482540104
Brand
GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS
Company
ARKRAY USA, INC.
Model
540010
Device description
The GLUCOCARD Shine Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
Published
2017-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K120351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120351000CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CAI-Sens, Inc.2012-05-03NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015482540101PackageGS150In Commercial Distribution
20015482540108PackageGS1500In Commercial Distribution
00015482540104PrimaryGS10
50015482540109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001548254010110015482540101
2001548254010820015482540108
00015482540104000154825401040154825401040015482540104
5001548254010950015482540109

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 Temperature34 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)566-8558xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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04987486053002S.G. Calibrator H111581N/A2025-12-19
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00015482601003Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482600013Assure® Titanium Blood Glucose Meter6000012025-09-15
10015482600508Assure® Titanium Blood Glucose Test Strips6000502025-09-15
10015482601000Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482510046Assure® Control - Control Solution Level 15100042019-04-01
00015482510053Assure® Control - Control Solution Level 25100052019-04-01
00015482510077Assure® Control - Control Solution Level 35100072019-04-01
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482511104GLUCOCARD® W Blood Glucose Monitoring System 5111002019-04-01
00015482512057GLUCOCARD® W Blood Glucose Test Strips5120502019-04-01
10015482102910ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
10015482102958ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
30015482501779Assure® Platinum Blood Glucose Meter5011772022-06-17

Other Devices Sharing Product Codes#

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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