GLUCOCARD® Expression™ Level 2 Control Solution

FDA UDI

Class II (US FDA UDI)

by Arkray Usa, Inc.

Identity

Trade Name: GLUCOCARD® Expression™ Level 2 Control Solution FDA UDI
Generic Name: Glucose IVD, control FDA UDI
Device Name: GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.) FDA UDI
Model / Reference: 570007 FDA UDI
Description: GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.) FDA UDI

Identifiers

Primary DI / UDI-DI: 00015482570071 FDA UDI
510(k) Number: K102037 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose IVD, control 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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 IVD, control

GLUCOCARD® Expression™ Level 2 Control Solution by Arkray Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose IVD, control.

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Cleared under the same submission

K102037 also covers:

GLUCOCARD® Expression™ Level 1 Control Solution — ARKRAY USA, INC.

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 12975523-4c34-4651-9dd6-6daf4daaa1c1 36 fields · synced Jun 8, 2026