HardyCHROM™ GA301

GUDID 00816576023264

HardyCHROM™ Candida, for the selective isolation and identification of Candida spp.

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 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: 00816576023264
• NIH Device Record Key: be3007a0-7f94-4e8c-8058-6d3bd3b19697
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HardyCHROM™
• Version Model Number: GA301
• Catalog Number: GA301
• 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: 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
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Some ingredients are very light sensitive. Store and incubate media in the dark.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576023264 [Unit of Use]
GS1	00816576023981 [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: 2021-10-15
• Device Publish Date: 2021-10-07

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