HardyCHROM

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name: HardyCHROM FDA UDI
Generic Name: Multiple formulation agar culture medium IVD FDA UDI
Device Name: Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology. FDA UDI
Model / Reference: J119 FDA UDI
Description: Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology. FDA UDI

Identifiers

Catalog Number: J119 FDA UDI
Primary DI / UDI-DI: 00816576026524 FDA UDI
FDA Product Code: JSH FDA UDI
KZI FDA UDI
GMDN Term: Multiple formulation agar culture medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2320 FDA UDI
866.2330 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: Multiple formulation agar culture medium IVD

HardyCHROM 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 dcc9e076-29d7-4843-a31d-92608dc963b5 36 fields · synced May 30, 2026