N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576027798
• Version / Model: W70
• Catalog Number: W70
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-06-08
• Public Version: 1
• Public Version Date: 2020-06-16
• Public Version Status: New
• Public Device Record Key: 33359a2d-f669-4e83-ba45-8ca65448122c

Device Description

SabDex (Sabouraud Dextrose) Agar, USP, for cultivation of yeast and fungi, 15x100mm plate, order by the package of 10 Sabouraud Dextrose Agar is recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts, and meet the harmonized USP/EP/JP standards for the microbial examination of non sterile products.

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: No
• 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
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	866.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576027781	GS1
Primary	00816576027798	GS1

Customer Contacts

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

Storage Conditions

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