VivaGuard Ino Blood Glucose Test Strips

FDA UDI

Class II (US FDA UDI)

by ABOUND Diagnostics, Inc

Identity

Trade Name: VivaGuard Ino Blood Glucose Test Strips FDA UDI
Generic Name: Home-use blood glucose spot-check system FDA UDI
Device Name: VivaGuard Ino Blood Glucose Test Strips FDA UDI
Model / Reference: VGS01-378 FDA UDI
Description: VivaGuard Ino Blood Glucose Test Strips FDA UDI

Identifiers

Catalog Number: VGS01-378 FDA UDI
Primary DI / UDI-DI: 00840423500028 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Home-use blood glucose spot-check system 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: Home-use blood glucose spot-check system

VivaGuard Ino Blood Glucose Test Strips by ABOUND Diagnostics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: ABOUND Diagnostics, Inc

Sources (1)

FDA UDI e6fc15b5-e3b4-4973-b297-873da10e624f 34 fields · synced Jun 1, 2026