UniStrip1 Generic Blood Glucose Test Strip

FDA UDI

Class II (US FDA UDI)

by Unistrip Technologies, Llc

Identity

Trade Name: UniStrip1 Generic Blood Glucose Test Strip FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Device Name: UniStrip1 Generic Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012. FDA UDI
Model / Reference: 024850 FDA UDI
Description: UniStrip1 Generic Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012. FDA UDI

Identifiers

Catalog Number: 024850 FDA UDI
Primary DI / UDI-DI: 00389167248501 FDA UDI
FDA Product Code: NBW FDA UDI
CGA 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

UniStrip1 Generic Blood Glucose Test Strip by Unistrip Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose IVD, kit, electrometry.

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EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
Tyson Bio 50H Blood Glucose Test Strip, 25T — TYSON BIORESEARCH INC. · Class II

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: Unistrip Technologies, Llc

Sources (1)

FDA UDI 6871fe86-34a6-44b9-b928-2319ffc4aabe 34 fields · synced Jun 8, 2026