N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398020947
• Version / Model: Z18
• Catalog Number: Z18
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 6853e0ce-dd3e-4fff-bad7-2fc057e8e5bd

Device Description

Hippurate Disks, 25 disks/jar. Hippurate disks are used for the sodium hippurate hydrolysis test. Glycine, an end product of hippurate hydrolysis, reacts with ninhydrin to produce a purple color. Hippurate is commonly used to presumptively identify Gardnerella vaginalis, Listeria monocytogenes, Campylobacter jejuni and group B streptococci.

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
Unit of Use	00819398020930	GS1
Primary	00819398020947	GS1

Customer Contacts

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

Storage Conditions

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