StatStrip

FDA UDI

Class II (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name: StatStrip FDA UDI
Generic Name: Glucose monitoring system IVD, point-of-care FDA UDI
Device Name: StatStrip Xpress Glucose Meter and Quick Reference Guide FDA UDI
Model / Reference: Xpress FDA UDI
Description: StatStrip Xpress Glucose Meter and Quick Reference Guide FDA UDI

Identifiers

Catalog Number: 43404 FDA UDI
Primary DI / UDI-DI: 00385480434041 FDA UDI
510(k) Number: K150461 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Glucose monitoring system IVD, point-of-care 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

Yes

FDA UDI

Over-the-Counter

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose monitoring system IVD, point-of-care

StatStrip by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose monitoring system IVD, point-of-care.

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Fresh Test — Fresh Test, LLC · Class II
GlucoLeader Enhance Blood Glucose Monitoring System(BR/BMT) — Hmd Biomedical, LLC · Class II
CURO L5 — KPI HEALTHCARE, INC. · Class II
Fresh Test — Fresh Test, LLC · Class II

Cleared under the same submission

K150461 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: Nova Biomedical Corporation

Sources (1)

FDA UDI a92901d2-d5a5-4422-99c5-f599fc849651 37 fields · synced Jun 6, 2026