HardyCHROM™ G307

GUDID 00816576020140

HardyCHROM™ MRSA A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staph aureus (MRSA). Not intended to diagnose infection or guide therapy. Further testing required for susceptibility or typing. LIGHT SENSITIVE.

HARDY DIAGNOSTICS

MRSA agar culture medium IVD, chromogenic

• Primary Device ID: 00816576020140
• NIH Device Record Key: ec9a9c39-8716-4cb3-9db8-7ee6444b79de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HardyCHROM™
• Version Model Number: G307
• Catalog Number: G307
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 10
• DM Exempt: true
• 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	00816576020140 [Primary]
GS1	00816576021239 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102922

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: 2016-09-01

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