HardyCHROM™ G323

GUDID 00816576025770

HardyCHROM™ CRE, 15x100mm Plate, 18ml HardyCHROM™ CRE is a selective and differential chromogenic agar medium intended for the qualitative and presumptive detection from stool specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES (Klebsiella aerogenes, Klebsiella oxytoca,Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens) that are non-susceptible to carbapenems as blue colonies.

HARDY DIAGNOSTICS

Multiple bacteria carbapenemase production IVD, kit, chromogenic
Primary Device ID00816576025770
NIH Device Record Keyc78d3510-f1a5-45c0-9c3c-e9e8f5ba3137
Commercial Distribution StatusIn Commercial Distribution
Brand NameHardyCHROM™
Version Model NumberG323
Catalog NumberG323
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-266-2222
Emailtechservice@hardydiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816576025763 [Unit of Use]
GS100816576025770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-29
Device Publish Date2019-10-21

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