N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398027304
• Version / Model: Z75
• Catalog Number: Z75
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-10
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: eb5422f5-ccc1-4e4a-8be5-00d12c67c890

Device Description

PYR Test Kit, 25 tests, with 5ml chromogenic developer, on paper disks A rapid test for Group A Strep and Enterococcus, both of which are PYR positive, all other streps are negative. A more reliable test for Group A Strep than bacitracin, the L-pyrrolidonyl -B-napthylamide impregnated disks serve as a substrate for the detection of pyrrolidonyl peptidase. Contains: PYR Test Disk (25) 00819398027038 Developer Reagent (1) 00819398028585

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

GMDN Terms

Code	Name	Definition	Implantable	Status
63421	Pyrrolidonyl arylamidase (PYR) activity IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of pyrrolidonyl arylamidase (PYR) activity in a clinical specimen and/or culture isolate within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test used in the laboratory or in point-of-care analyses typically to differentiate Group A streptococci and enterococci from Group D streptococci. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398027304	GS1

Customer Contacts

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

Storage Conditions

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