N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398027427
• Version / Model: Z73
• Catalog Number: Z73
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: a36717d0-0445-4d96-b16d-46b5222d7121

Device Description

Nitrate Reagent C, Zinc Dust, 5gm For the completion of the nitrate reduction test. Confirms negatives after adding Nitrate A, product number Z124 or Z71; and Nitrate B, product number Z125 or Z72 reagents. True negatives will turn red after the zinc dust is added.

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
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35841	Nitrate reduction microbial reagent IVD	One or multiple substances or reactants intended to be used in microbial testing to detect nitratase enzyme production, by demonstrating the reduction of nitrate through a visible colour change in an organism isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398027427	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius