Easy Step Blood Glucose Test Strips 50ct

FDA UDI

Class II (US FDA UDI)

by Home Aide Diagnostics, Inc.

Identity

Trade Name: Easy Step Blood Glucose Test Strips 50ct FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Device Name: 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system FDA UDI
Model / Reference: T5D2-00 FDA UDI
Description: 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system FDA UDI

Identifiers

Catalog Number: 1195 FDA UDI
Primary DI / UDI-DI: 00891237001195 FDA UDI
510(k) Number: K090629 FDA UDI
FDA Product Code: CGA FDA UDI
NBW FDA UDI
GMDN Term: Glucose IVD, kit, electrometry 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

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, kit, electrometry

Easy Step Blood Glucose Test Strips 50ct by Home Aide Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K090629 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: Home Aide Diagnostics, Inc.

Sources (1)

FDA UDI 54af7c3b-fb14-42de-8576-0267df64ca0a 37 fields · synced Jun 8, 2026