HardyCHROM J119

GUDID 00816576026517

Blood Agar 5% / HardyCHROM™ UTI, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. HardyCHROM™ UTI is a non-selective chromogenic medium recommended for the cultivation, differentiation and enumeration of urinary tract pathogens based on colony color and morphology.

HARDY DIAGNOSTICS

Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD Multiple formulation agar culture medium IVD

• Primary Device ID: 00816576026517
• NIH Device Record Key: dcc9e076-29d7-4843-a31d-92608dc963b5
• Commercial Distribution Discontinuation: 2023-09-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HardyCHROM
• Version Model Number: J119
• Catalog Number: J119
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576026517 [Unit of Use]
GS1	00816576026524 [Primary]

FDA Product Code

• JSH: Culture Media, Non-Selective And Differential

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-25
• Device Publish Date: 2020-05-20

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