N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576028085
• Version / Model: J79
• Catalog Number: J79
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-24
• Public Version: 1
• Public Version Date: 2020-06-01
• Public Version Status: New
• Public Device Record Key: 8a48c14f-8949-49a9-bb08-2a5e9bcfcff6

Device Description

All Purpose Quad Plate (Eosine Methylene Blue (EMB) Agar / Mannitol Salt Agar (MSA) / Mycobiotic Agar / Blood Agar, 5%), 15x100mm Quadplate, 5ml/section. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Mannitol Salt Agar (MSA) is recommended for use as a selective and differential medium for the isolation of pathogenic staphylococci. Hardy Diagnostics Mycobiotic Agar is recommended for use in the isolation of pathogenic fungi from clinical specimens.

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
JSI	Culture Media, Selective And Differential	Microbiology	866.2360	1
JSJ	Culture Media, Selective And Non-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	00816576028078	GS1
Primary	00816576028085	GS1

Customer Contacts

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

Storage Conditions

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