HardyDisk™

Basic Information

• Brand Name: HardyDisk™
• Primary DI: 00816576028306
• Version / Model: Z7025
• Catalog Number: Z7025
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• 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: 38e44df0-6ea6-4d9a-b907-25b0194e2253

Device Description

Bacitracin 0.04 units, HardyDisks™, for the differentiation of Group A Strep (Streptococcus pyogenes), 50 disks per cartridge, 5 cart., not for antimicrobial sensitivity tests, Used in the presumptive identification of group A, beta-hemolytic streptococci. The test differentiates group A streptococci from other Lancefield groups of hemolytic streptococci by inhibiting the growth of group A streptococci around a disk containing approximately 0.04 units bacitracin.

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
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	866.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43680	Bacitracin differentiation disc IVD	One or multiple diagnostic discs impregnated with bacitracin test reagents intended to be used for the differentiation of Lancefield Group A Streptococci from other beta-haemolytic Streptococci bacteria isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576028290	GS1
Primary	00816576028306	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011086	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius