HardyCHROM™ J28

GUDID 00816576026838

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.

HARDY DIAGNOSTICS

Multiple formulation agar culture medium IVD

• Primary Device ID: 00816576026838
• NIH Device Record Key: bcb28a42-2158-4b0c-a031-3b32d3b2250f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HardyCHROM™
• Version Model Number: J28
• Catalog Number: J28
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576026838 [Unit of Use]
GS1	00816576026845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160512

FDA Product Code

• JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [HardyCHROM™]

• 00816576023097: HardyCHROM™ ESBL A chromogenic medium for use as a primary screening method for the detection
• 00816576020140: HardyCHROM™ MRSA A selective and differential chromogenic medium for the qualitative direct de
• 00816576020096: HardyCHROM™ MRSA - RSR A selective and differential chromogenic medium for the qualitative dir
• 00816576025770: HardyCHROM™ CRE, 15x100mm Plate, 18ml HardyCHROM™ CRE is a selective and differential chromo
• 00816576023264: HardyCHROM™ Candida, for the selective isolation and identification of Candida spp.
• 00819398020541: HardyCHROM™ Campy Agar, 15x100mm plate, 10/pk. Screening medium for the selective isolation an
• 00816576026838: HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a sele