N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576023646
• Version / Model: 3001
• Catalog Number: 3001
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-27
• Public Version: 2
• Public Version Date: 2023-10-10
• Public Version Status: Update
• Public Device Record Key: eb6fcc39-c98e-48cf-b74b-96e8c8406700
• Distribution End Date: 2023-10-09

Device Description

EMB/TSA with Blood/Staph Select, 15x100, Triplate, 10/pk For cultivation and differentiation of microorganisms Section I: ECM Levine Agar Section II: TSA with 5% Sheep Blood Section III: Staph Selective

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
JSH	Culture Media, Non-Selective And Differential	Microbiology	866.2320	1
JSI	Culture Media, Selective And Differential	Microbiology	866.2360	1
KZI	Culture Media, Enriched	Microbiology	866.2330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of 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	00816576023639	GS1
Primary	00816576023646	GS1

Customer Contacts

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

Storage Conditions

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