N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398027434
• Version / Model: Z70
• Catalog Number: Z70
• 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: ce23c356-49e3-4f9e-a815-afcf8427b367

Device Description

Ninhydrin Reagent, for hippurate test, in alcohol, 15ml For use in rapid determination of sodium hippurate hydrolysis reactions in bacteria. Useful for the presumptive identification of Campylobacter, Listeria, and Gardnerella vaginella.

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
43702	Hippurate hydrolase microbial reagent IVD	A substance or reactant intended to be used in microbial testing to detect the enzyme hippurate hydrolase, produced by a microorganism 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	00819398027434	GS1

Customer Contacts

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

Storage Conditions

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