N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398026437
• Version / Model: Z205
• Catalog Number: Z205
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-06-16
• Public Version: 1
• Public Version Date: 2020-06-24
• Public Version Status: New
• Public Device Record Key: 7605ac38-f5e8-435d-8bb7-eb95f3cc8475

Device Description

Rapid Trehalose Broth, 0.35ml, for Candida glabrata, optically clear, shatter resistant, polycarbonate tube, 20 tests per package Carbon Assimilation Test. For the identification of yeasts, especially Candida (Torulopsis) glabrata.

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
36016	Trehalose utilization microbial reagent IVD	A substance or reactant intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to ferment the carbohydrate trehalose.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398026420	GS1
Primary	00819398026437	GS1

Customer Contacts

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

Storage Conditions

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