GenUltimate

FDA UDI

Class II (US FDA UDI)

by Pharma Tech Solutions, Inc.

Identity

Trade Name: GenUltimate FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Device Name: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters FDA UDI
Model / Reference: 300-25 FDA UDI
Description: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters FDA UDI

Identifiers

Primary DI / UDI-DI: 00850015460036 FDA UDI
510(k) Number: K103542 FDA UDI
FDA Product Code: 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

Yes

FDA UDI

Category: Glucose IVD, kit, electrometry

GenUltimate by Pharma Tech Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose IVD, kit, electrometry.

VivaGuard Ino — Able Diagnostics Inc · Class I
TruePoint — OK BIOTECH CO., LTD. · Class II
VivaGuard Ino — Able Diagnostics Inc · Class II
Easy Talk Blood Glucose Testing Strips 25ct — HOME AIDE DIAGNOSTICS, INC. · Class II
FORA — FORA CARE INC. · Class II
OneTouch Ultra — Lifescan, Inc. · Class II
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

Cleared under the same submission

K103542 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: Pharma Tech Solutions, Inc.

Sources (1)

FDA UDI bbdf07e1-f766-4df0-8b0a-ffb0267848e6 35 fields · synced Jun 6, 2026