HardyCHROM™ G321

GUDID 00816576023097

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.

HARDY DIAGNOSTICS

ESBL Enterobacteriaceae agar culture medium IVD, chromogenic ESBL Enterobacteriaceae agar culture medium IVD, chromogenic ESBL Enterobacteriaceae agar culture medium IVD, chromogenic

• Primary Device ID: 00816576023097
• NIH Device Record Key: d785fecf-87f5-43a8-a788-f6277347508b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HardyCHROM™
• Version Model Number: G321
• Catalog Number: G321
• 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: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576023080 [Unit of Use]
GS1	00816576023097 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-28

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