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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™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogenic medium intended for the qualitative and presumptive detection from stool, rectal swabs, and related specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES that are non-susceptible to carbapenems as blue colonies. HardyCHROM™ ESBL s a selective and differential chromogenic medium that is intended for the qualitative and presumptive detection from stool specimens of 1) Enterobacterales that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae , and Klebsiella oxytoca. FDA UDI
Model / Reference
J28 FDA UDI
Description
HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogenic medium intended for the qualitative and presumptive detection from stool, rectal swabs, and related specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES that are non-susceptible to carbapenems as blue colonies. HardyCHROM™ ESBL s a selective and differential chromogenic medium that is intended for the qualitative and presumptive detection from stool specimens of 1) Enterobacterales that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae , and Klebsiella oxytoca. FDA UDI

Identifiers

Catalog Number
J28 FDA UDI
Primary DI / UDI-DI
00816576026845 FDA UDI
510(k) Number
K160512 FDA UDI
K190553 FDA UDI
FDA Product Code
JSO 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
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple formulation agar culture medium IVDMultiple bacteria carbapenemase production IVD, kit, chromogenic

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

Similar devices

Also classified as Multiple bacteria carbapenemase production IVD, kit, chromogenic.

Cleared under the same submission

K160512 also covers:

K190553 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI bcb28a42-2158-4b0c-a031-3b32d3b2250f 37 fields · synced May 31, 2026