OxiStrips™

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name: OxiStrips™ FDA UDI
Generic Name: Oxidase production microbial reagent IVD FDA UDI
Device Name: OxiStrips™, Oxidase test, 25 paper strips per package OxiStrips™ Oxidase Strips are ready to use test strips with a convenient plastic handle so the user can avoid skin contact with the reaction area and are used for the detection of cytochrome oxidase activity in bacteria FDA UDI
Model / Reference: Z93 FDA UDI
Description: OxiStrips™, Oxidase test, 25 paper strips per package OxiStrips™ Oxidase Strips are ready to use test strips with a convenient plastic handle so the user can avoid skin contact with the reaction area and are used for the detection of cytochrome oxidase activity in bacteria FDA UDI

Identifiers

Catalog Number: Z93 FDA UDI
Primary DI / UDI-DI: 00819398028721 FDA UDI
FDA Product Code: JTO FDA UDI
GMDN Term: Oxidase production microbial reagent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2660 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Oxidase production microbial reagent IVD

OxiStrips™ by Hardy Diagnostics — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Hardy Diagnostics

Sources (1)

FDA UDI 01c4b340-8c61-4bf8-9673-5d9169f27dc1 36 fields · synced May 30, 2026