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HardyCHROM

FDA UDI

Class I (US FDA UDI)

by Hardy Diagnostics

Identity

Trade Name
HardyCHROM FDA UDI
Generic Name
Differential/selective agar culture medium IVD FDA UDI
Device Name
HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium recommended for the selective isolation and differentiation of Cronobacter (Enterobacter) sakazakii from other members of the family Enterobacteriaceae based on colony color. FDA UDI
Model / Reference
G315 FDA UDI
Description
HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium recommended for the selective isolation and differentiation of Cronobacter (Enterobacter) sakazakii from other members of the family Enterobacteriaceae based on colony color. FDA UDI

Identifiers

Catalog Number
G315 FDA UDI
Primary DI / UDI-DI
10819398028421 FDA UDI
FDA Product Code
JSH FDA UDI
GMDN Term
Differential/selective agar culture medium IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2320 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA UDI 854d4173-b76e-4928-8a6a-491c9e3ecbe4 37 fields · synced May 30, 2026