Urease

Basic Information

• Brand Name: Urease
• Primary DI: 00893029002571
• Version / Model: GIS-62-2ML
• Catalog Number: GIS-62-2ML
• Company Name: GI Supply, Inc.
• Labeler DUNS: 160990313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-08
• Public Version: 1
• Public Version Date: 2021-07-16
• Public Version Status: New
• Public Device Record Key: 201b0a69-12d5-4def-9070-830594f8b6e1

Device Description

Urease Glycerol Solution

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: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYR	Helicobacter Pylori	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51027	Helicobacter pylori urease IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00893029002571	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012411	000

Storage Conditions

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