GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS

FDA UDI

Class II (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 542050 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482540500 FDA UDI
510(k) Number: K120351 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS by Arkray Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K120351 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Arkray Usa, Inc.

Sources (1)

FDA UDI 10310427-4cf4-454e-bb46-43c634066b29 36 fields · synced May 30, 2026