N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398026857
• Version / Model: Z14
• Catalog Number: Z14
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-06-11
• Public Version: 1
• Public Version Date: 2020-06-19
• Public Version Status: New
• Public Device Record Key: 93882040-ccf3-4435-a29f-47afb03871c1

Device Description

Rapid Anginosus ID Kit, to assist in the identification of Streptococcus anginosis (S. milleri), 10 tests per kit For the rapid identification of the Streptococcus anginosus group (formerly S. milleri) by the detection of arginine decarboxylase activity and production of acetoin. Results in as little as four hours. Easy color change readout, time saving kit format is cost effective. Each kit contains: 10 tubes of Rapid Arginine 10 tubes of Rapid VP

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
JSE	Culture Media, Multiple Biochemical Test	Microbiology	866.2320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43509	Voges-Proskauer (VP) microbial reagent IVD	One or multiple substances or reactants, referred to as VP (Voges-Proskauer) reagent, intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to convert pyruvate to acetoin.	No	Active
51838	Multiple Vibrio species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Vibrio bacteria isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398026857	GS1
Unit of Use	00819398027045	GS1

Customer Contacts

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

Storage Conditions

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