HardyCHROM

FDA UDI

Class II (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name: HardyCHROM FDA UDI
Generic Name: Multiple formulation agar culture medium IVD FDA UDI
Device Name: HardyCHROM™ MRSA/ HardyCHROM™ Staph aureus, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. HardyCHROM™ Staph aureus is a chromogenic medium recommended for the isolation, differentiation, and enumeration of Staphylococcus aureus by colony color FDA UDI
Model / Reference: J35 FDA UDI
Description: HardyCHROM™ MRSA/ HardyCHROM™ Staph aureus, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. HardyCHROM™ Staph aureus is a chromogenic medium recommended for the isolation, differentiation, and enumeration of Staphylococcus aureus by colony color FDA UDI

Identifiers

Catalog Number: J35 FDA UDI
Primary DI / UDI-DI: 00816576026807 FDA UDI
FDA Product Code: JSO FDA UDI
JSI FDA UDI
GMDN Term: Multiple formulation agar culture medium IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1700 FDA UDI
866.2360 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

FDA UDI

Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Multiple formulation agar culture medium IVD

HardyCHROM by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Multiple formulation agar culture medium IVD.

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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: Hardy Diagnostics

Sources (1)

FDA UDI bb982598-28e9-4196-ba33-a1e5c05a6cd5 36 fields · synced Jun 8, 2026