HardyCHROM™

Basic Information

• Brand Name: HardyCHROM™
• Primary DI: 00819398020541
• Version / Model: G339
• Catalog Number: G339
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-03-24
• Public Version: 2
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: 771c0c81-79a4-4124-bb4a-34734782fd58

Device Description

HardyCHROM™ Campy Agar, 15x100mm plate, 10/pk. Screening medium for the selective isolation and chromogenic differentiation of Campylobacter jejuni, C.lari, C.coli, and C.fetus from direct stool cultures, or from food or poultry samples. Some ingredients are very light sensitive. Store and incubate media in the dark.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSI	Culture Media, Selective And Differential	Microbiology	866.2360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398020541	GS1
Unit of Use	00819398020534	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius