N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398026567
• Version / Model: Z54
• Catalog Number: Z54
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-08-07
• Public Version: 1
• Public Version Date: 2020-08-17
• Public Version Status: New
• Public Device Record Key: f0aa0220-2ddd-4b75-a763-5b170fc911d9

Device Description

Rapid Urea Medium, useful for Helicobacter pylori, 2ml, 15x45mm tube, 10 per box Rapid Urea Medium for rapid detection of urease activity in Helicobacter pylori, Cryptococcus neoformans, or Proteus spp. Biopsy specimen from endoscopy can be submerged into the agar, positive reactions (pink-red color) may be noted within minutes.

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: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSF	Culture Media, Single Biochemical Test	Microbiology	866.2320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58684	Differential/selective broth culture medium IVD	A broth 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 in the same medium. 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
Unit of Use	00819398026550	GS1
Primary	00819398026567	GS1

Customer Contacts

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

Storage Conditions

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