HardyCHROM™

FDA UDI

Class II (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name: HardyCHROM™ FDA UDI
Generic Name: ESBL Enterobacteriaceae agar culture medium IVD, chromogenic FDA UDI
Device Name: HardyCHROM™ ESBL A chromogenic medium for use as a primary screening method for the detection and differentiation of Extended-Spectrum Beta-Lactamase producing Enterobacteriaciae. Some ingredients are very light sensitive. Store and incubate in the dark. FDA UDI
Model / Reference: G321 FDA UDI
Description: HardyCHROM™ ESBL A chromogenic medium for use as a primary screening method for the detection and differentiation of Extended-Spectrum Beta-Lactamase producing Enterobacteriaciae. Some ingredients are very light sensitive. Store and incubate in the dark. FDA UDI

Identifiers

Catalog Number: G321 FDA UDI
Primary DI / UDI-DI: 00816576023097 FDA UDI
510(k) Number: K160512 FDA UDI
FDA Product Code: JSO FDA UDI
GMDN Term: ESBL Enterobacteriaceae agar culture medium IVD, chromogenic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1700 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

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: ESBL Enterobacteriaceae agar culture medium IVD, chromogenic

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

Cleared under the same submission

K160512 also covers:

HardyCHROM™ — HARDY DIAGNOSTICS

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 d785fecf-87f5-43a8-a788-f6277347508b 37 fields · synced May 30, 2026