CatScreen™

Basic Information

• Brand Name: CatScreen™
• Primary DI: 00819398028554
• Version / Model: Z110
• Catalog Number: Z110
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-07-09
• Public Version: 1
• Public Version Date: 2020-07-17
• Public Version Status: New
• Public Device Record Key: d8b019a8-c33f-49a5-8b00-987af34ee78f

Device Description

CatScreen™, rapid test for Moraxella (Branhamella) catarrhalis (M. cat.)using butyrate esterase, 25 disks tests per package Rapid test for the detection of the enzyme butyrate esterase in bacteria isolated on culture media for the presumptive identification of Branhamella (Moraxella) catarrhalis. Performs a butyrate test within 5 minutes. Simply moisten disk, inoculate with organism, then wait for the development of a red color.

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: No
• 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
50420	Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398027267	GS1
Primary	00819398028554	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960996	000

Storage Conditions

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