HardyCHROM G343

GUDID 00816576023103

HardyCHROM Candida + auris Recommended for the selective isolation and differential identification of yeast. The medium allows for the differentiation of C. albicans , C. tropicalis, C. krusei, and C. auris based on colony morphology, color, and positive UV fluorescence. This medium facilitates the detection of mixed yeast cultures.

HARDY DIAGNOSTICS

Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD

• Primary Device ID: 00816576023103
• NIH Device Record Key: 4e5f1eec-cb61-4f50-b329-4ccb74e314b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HardyCHROM
• Version Model Number: G343
• Catalog Number: G343
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@hardydiagnostics.com
• Phone: 8002662222
• Email: technicalservices@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576023103 [Unit of Use]
GS1	00816576023370 [Primary]

FDA Product Code

• JSI: Culture Media, Selective And Differential

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: 2021-09-02
• Device Publish Date: 2021-08-25

On-Brand Devices [HardyCHROM]

• 00816576029112: HardyCHROM Group A Strep Agar (RSR) A chromogenic medium recommended for the selective cultivati
• 00816576029082: HardyCHROM Group A Strep Agar A chromogenic medium recommended for the selective cultivation and
• 00816576023103: HardyCHROM Candida + auris Recommended for the selective isolation and differential identificati
• 00819398028424: HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium
• 00816576026517: Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar pr