INFINITY™ Test Strips

FDA UDI

Class II (US FDA UDI)

by U.s. Diagnostics Inc.

Identity

Trade Name: INFINITY™ Test Strips FDA UDI
Generic Name: Glucose IVD, kit, electrometry FDA UDI
Model / Reference: IGM-0024 FDA UDI

Identifiers

Catalog Number: G5-203S50 FDA UDI
Primary DI / UDI-DI: 10885502002007 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

Dimensions & Sizes

Size: Total Volume — 0.5 Microliter FDA UDI

Category: Glucose IVD, kit, electrometry

INFINITY™ Test Strips by U.s. Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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EasyMax 15 Blood Glucose Test Strip — EPS BIO TECHNOLOGY CORP. · Class II
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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: U.s. Diagnostics Inc.

Sources (1)

FDA UDI 1815c211-0b92-439c-b276-3371eb8a4787 36 fields · synced May 30, 2026